MD Recalls 2011-Eng

MEDICAL DEVICES RECALL LISTINGS: 2011
Recall Posting Date 2011-01-10 Hazard Classification Type II A) 1009-9012-000 B) 1009-9000-000 C) 1009-9002-000
Trade Name
Manufacturer
Recall Start Date
Recall Number
Model or Catalog #
Lot or Serial #
Reason for Recall
A) S/5 Aespire 7900 SmartVent Anesthesia System B) S/5 Aespire Anesthesia Machine C) GE Darex-Ohmeda Avance Anesthesia System
Datex-Ohmeda, Inc. DBA GE Healthcare
2010-05-07 54484
A) >10 Numbers, Contact Manufacturer B) AMXN00185, AMXN00499, AMXM01179, AMXL00152, AMXL00260, AMXL02044, AMXL00153, AMXM00411, AMXM00843, AMXM00845 C) >10 Numbers, Contact Manufacturer A) All lots B) All lots C) All lots D) All lots E) All lots F) All lots G) All lots H) All lots I) All lots J) All lots S/N 00000000863M21
Potential for O2 flush button to become impeded by the work surface & to stick in the open or partially open position, resulting in flow of O2 into the breathing system causing dilution of anaesthetic agent.
A) Synchron LX20 System Analyzer - Class 2 B) Unicel DXC 600 C) Unicel DXC 800 D) Unicel DXC 600I Synchron Access Clinical Analyzer E) Unicel DXC 880I Synchron Access Clinical Analyzer F) Synchron LXI 725 G) Synchron LX20 Pro H) Unicel DXC 660I Synchron Access Clinical Analyzer I) Unicel DXC 680I Synchron Access Clinical Analyzer J) Unicel DXC 860I Synchron Access Clinical Analyzer Discovery MR450 1.5T MR System - Main Unit
Beckman Coulter, Inc.
2011-01-10
2010-10-18 58420
Type II
GE Medical Systems LLC
2011-01-10
2010-11-17 58680
Type II
A) 466002 B) 4764 C) 4764 D) 4767 E) 4768 F) 476501 G) 476100 H) 4771 I) 4772 J) 4773 Discovery MR450 1.5T MR System
For user-defined chemistries (UDRS) in the Synchron LX and Unicel DXC Clinical Systems, the polychrome correction is not automatically updated when wavelengths are modified.
Gradient cooling manifolds used on affected system may contain electrically conductive hoses, which become live when gradient system is powered on. Potential for electric shock. Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BHCG Assay. The recall has been initiated due to incorrect expiration dating. The product has a two year shelf life and not five years as indicated on the labelling. This error doesn't impact the sterility of the product. In case of a breakage of the Beamview TI camera cable, it may be possible that the camera housing is exposed to the operating voltage of 100 vdc. As a consequence of this exposure the persons performing repair or maintenance tasks may sustain an electric shock. This issue does not occur during normal clinical operation since cables and electrical components are enclosed behind the covers. The displayed values in the CCA application for the Extended Brilliance Workspace should be labelled as being the percentage of increase in the wall thickness between the end diastolic and the end systolic states, but what is actually being displayed is the decrease in wall thickness from the end systolic to the end diastolic state.
Access System - Total BHCG Assay Classic Style Fine Tip Pen with Ruler & Labels
Beckman Coulter, Inc. Cardinal Health
2011-01-10 2011-01-10
2010-11-08 59044 2010-11-16 59306
Type II Type II
33500, 33505 250FPRL
All lots 2015-07-08
A) Mevatron Linear Accelerator B) Oncor Impression 3D Plus
Siemens AG
2011-01-10
2010-11-25 59311
Type III
A) 4504200 B) 5857912
A) 3291, 3356, 3619, 3645, 3638, 3919, 2618, 2616 B) 3799
A) Brilliance 64 Slice CT System - Extended Brilliance Workspace (EBW) B) Brilliance CT Big Bore System - Extended Brilliance Workspace Portal C) Brilliance ICT System - Extended Brilliance Workspace D) Brilliance 40/64 Slice CT System - Extended Brilliance Workspace Portal E) Brilliance ICT System - Extended Brilliance Workspace Portal Kolibri Spectra Camera Kit O-Arm 1000 Imaging System - Main Unit Definition + Definition Flash Vial-Mate Adaptor
Philips Medical Systems (Cleveland), Inc.
2011-01-10
2010-09-29 59355
Type II
A) 4550 110 02031 B) 4550 110 02101 C) 4550 110 02031 D) 4550 110 02101 E) 4550 110 02101
A) 80338, 7379 B) 80025 C) 11019 D) 80063, 80258 E) 80588, 80662
Brainlab AG Medtronic Navigation, Inc. (Littleton) Siemens AG Baxter Healthcare Corporation
2011-01-10 2011-01-10 2011-01-10 2011-01-10
2010-11-30 59387 2010-10-18 58889 2010-11-25 59312 2010-12-02 59460
Type II Type II Type III Type II
18117 9732719 77 40 769 2B8071
5572110001 S/N'S 00213, 00263, 00243, 00144, 00304, 00358, 00334, 00174 60199, 60206, 60235, 60422 >10 Numbers, Contact Manufacturer
There exists a small probability that specific Spectra cameras may return incorrect data, resulting in navigation inaccuracies or in stopping of camera tracking. Potential door cable failure. This update instruction provides optimization of main unit due to malfunction of the dose modulation at child head sequence which may lead to bad image quality. Baxter has become aware that the Vial-Mate vial reconstitution device is not fully effective when used with I.V. bags that do not contain a minimum amount of air. The Viaflex bags currently marketed in Canada are not injected with air during production and may not contain this minimum amount of air. Therefore, incomplete reconstitution may result when the Vial-Mate device is used with the Viaflex bags. A potential danger by the image intensifier system with perivision options. During perivision the image system can sporadically crash. The customer has to repeat the perivision and to apply contrast media and x-ray to the patient.
A) Axiom Artis DTA B) Axiom Artis FA Alpha C) Axiom Artis MP Diagnostic D) Axiom Artis DBC Magnetic Navigation Updated recall # 56246 previously posted on 2010-09-13. Greenlight PV Laser System
Siemens AG
2011-01-10
2010-08-18 56246
Type III
A) 7008605 B) 5904441 C) 5904466 D) 59 17 054
A) 32070 B) 25006, 25055, 25076, 25147, 20002, 200188 C) 20069, 20070, 20151, 20163, 20215 D) 14041
American Medical Systems
2011-01-10
2010-02-17 53649
Type III
0010-1155
534g, 543h, 537g, 310c, 1 unknown
A) 1.0T Signa Horizon Magnetic Resonance System B) 1.5T Signa Horizon Magnetic Resonance System C) 1.5T Signa Horizon LX Magnetic Resonance System D) Signa 1.5T Excite HD - Magnet E) 3.0T Signa HDX MR System - Main Unit F) 1.5T Signa HDX MR System - Main Unit G) Discovery MR750 MR System - Magnet H) 1.5T Signa Infinity Twinspeed with Excite I) Signa 3T MR System - Parts for Main Unit J) Signa Excite 3.OT G3 Magnet K) Signa HDXT 1.5T MR System - Main Unit L) Discovery MR450 1.5T MR System - Main Unit M) Signa HDI 1.5T MRI System - 16 Channel Centricity Laboratory - Instrument Interfacing
2011-01-10
2010-11-02 56975
Type II
A) M1800MA B) M1000MA C) M1000RA/RD/RF/RG D) M1060LG E) M3335JK F) M3335J, M3335JA, M3335JG G) M7000MA, M7000MC H) M3000TD I) M1060YW J) M3333TD K) Signa HDXT 1.5T MR System L) Discovery MR450 1.5T MR System M) S7504HP Instrument Interfacing
A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers D) All Serial Numbers E) All Serial Numbers F) All Serial Numbers G) All Serial Numbers H) All Serial Numbers I) All Serial Numbers J) All Serial Numbers K) All Serial Numbers L) All Serial Numbers M) All Serial Numbers Software Version 4.0.0.9 or Higher & Software Version 4.1.0 or Higher All Character User Interface (CUI) Versions / Releases 4501186856
It is possible for persons in the operating room to inadvertently back into the Greenlight PV fibre at the connection to the laser console which may cause the fibre to break and cause a burn. Potential for failure for users to provide an obstacle free service path outside the 200g field & not having another trained person on site, resulting in death or serious injury to service engineers.
GE Healthcare IT
2011-01-10
2010-08-18 58393
Type III
Under specific conditions the laboratory system may truncate a value on an instrument rerun (eg. A result of 1.025 would be truncated at 1. And reported as 1.000). Under specific conditions, the laboratory system may incorrectly, report results of 0 for tests that have not yet been resulted. Some system control units (SCU) manufactured April - July 2010 have a defect that may result in the SCU losing communication, which may cause the optical tracking system to intermittently cycle or stop working.
Centricity Laboratory - Core Lab Stealthstation S7 - Cart
GE Healthcare IT Medtronic Navigation, Inc.
2011-01-10 2011-01-10
2010-08-18 58397 2010-11-08 58590
Type II Type II
Core 9733856
A) Discovery ST16 (Multislice) - Main Unit B) Angioct FP16 System C) Discovery SET16 PET/CT Scanner System D) Discovery RX PET/CT Scanner System E) Lightspeed 16 CT Scanner System
GE Healthcare Japan Corpoation
2011-01-10
2010-11-18 58887
Type III
A) S9116LA B) A90962AC C) S9116LE/ME D) S9116LR E) B7868JA/JD
Heartstart FR2+ Semiautomatic Defibrillator - Main Unit
Philips Medical Systems
2011-01-10
2010-11-30 59418
Type II
M3860A, M3861A
A) 00000369417CN1, 00000385376CN9, 00000391656CN6, 00000393942CN8, 00000411721CN4 B) 00000005070YC8 C) 00000404536CN5, 00000406414CN3, 00000388336CN0 D) 00000406672CN6, 00000413213CN0 E) >10 Numbers, Contact Manufacturer N/A
Certain computed tomography dose index (CTDI) adjustment factors used for manual calculation from technical reference manual (TRM) are incorrect, which may lead to inaccurate CTDI manual calculation.
Sterile Intermediary Tube Sets
Depuy Mitek
2011-01-10
2010-12-03 59521
Type II
281142
>10 Numbers, Contact Manufacturer
Indura Closed-Tip Intrathecal Catheter A) ACL Elite B) ACL Elite Pro C) ACL 9000 Foley Catheter Tray Legionella Growth Supplement Elecsys Anti-Tg
Medtronic Inc. Instrumentation Laboratory Co.
2011-01-10 2011-01-10
2010-10-01 57324 2010-11-11 58956
Type I Type II
8731SC A) 0000880311 B) 0001000311 C) 0000990011 85-5037 SR0110C 04738578191
>10 Numbers, Contact Manufacturer A) 05010100 to 10111176 B) 05010100 to 10111779 C) 00040105 to 09031882 71499 906009 >100 Numbers, Contact Manufacturer
Benlan Inc. Oxoid Limited Roche Diagnostics GMBH
2011-01-10 2011-01-10 2011-01-10
2010-11-17 59025 2010-11-17 59075 2010-11-29 59326
Type III Type II Type III
Affected units may contain a component called a flash memory that was improperly relabelled by a third party, and therefore Philips cannot with certainty identify the source, quality, and date of manufacture of the component. This recall has been initiated because there is a potential that the sterile barrier seals on the product pouch in the affected lots may not be completely sealed, which could result in a possible breach of sterility. Potential that the 11.4 cm introducer needle within certain lots of model 8731SC Intrathecal Catheter Kits may exceed USP requirements for bacterial endotoxin. During testing of the ACL 8000/9000/10000/ACL Elite/ACL Elite Pro, sporadically lowered APTT results were observed with available IL locked PT/APTT test groups. (Specifically the recombiplastin PT / synthasil APTT / recombiplastin PT/APPTT-SP test group). Description reads "Urethral Catheter Tray" instead of "Foley Catheter Tray". Product may contain low level microbial contamination which could result in contaminated media. There is a possibility to obtain falsely elevated anti-Tg results caused by the interaction with high thyroglobulin (Tg) concentration (>2000ng/ml) present in patient sample. When the user imports two or more image series and changes the viewing direction for both image series, there is a potential that the orientation of the second image series is not stored correctly by the system. This could result in two different discrepancies: 1) the automatic correlation algorithm may not achieve a good correlation result and 2) the second image series may be shown with the wrong orientation. Potential defect in the manufacturing process of the plastic support of the Chemstrip 10A test strips for specific lots which can lead to a workflow interruption. Covidien is conducting a recall of specific lots of the Ligasure Blunt Tip Laparoscopic Sealer/Divider. The recall is in response to reports that during surgical procedures the device may energize when clamping without pushing the activation button. 1) Open channel on NIM 3.0 system, which was traced to internal cable strain relief that could be too long. 2) An inductor (lead) could break free from the board inside the patient interface. Possibility of part number 01-7710 (1.5 6 hole regular double Y plate) package may have contained another part number 01-7112 ( 1.5 6 hole long double Y) instead. These tables can become contaminated with fluids in an area that is not easily accessible for cleaning. 1. Instructions for use have not been provided to customers, including potential hazards associated with improper use and handling by improperly trained personnel, could lead to serious injury. 2. Customers not aware of the recommended 5 year inspection for these regulators, ensuring their continued integrity and safe working operation. 1. Instructions for use have not been provided to customers, including potential hazards associated with improper use and handling by improperly trained personnel, could lead to serious injury. 2. Customers not aware of the recommended 5 year inspection for these regulators, ensuring their continued integrity and safe working operation. Changes were made to the instruction manual.
Stryker Navigation System - Intellect Cranial Software
Stryker Leibinger GMBH & Co. KG
2011-01-10
2010-11-30 59427
Type II
6000-650-000, 6000-650-100, 6000-651-000, 6000-651-200, 6000-652-000
3001, 3002, 3003, 3004, 3010, 3031
Chemstrip 10A
Roche Diagnostics GMBH
2011-01-10
2010-12-02 59429
Type III
11379208119
Ligasure Blunt Tip Laparoscopic Sealer/Divider
Covidien LLC
2011-01-10
2010-12-09 59607
Type II
LF1537
200013xx, 200014xx, 200015xx, 200016xx, 200166xx, 200168xx, 200169xx, 200309xx, 200310xx, 201438xx, 202010xx 190307, 191224, 191661, 192093, 192664, 193207, 193331, 193333 A) 00439, 00483, 00611, 00608, 00268, 00484, 00264, 00585 B) 00585 753120 & 693500
A) NIM-Response 3.0 Patient Interface B) NIM-Neuro 3.0 Patient Interface 1.5 mm Plate
Medtronic Xomed Inc.
2011-01-10
2010-09-27 56860
Type II
A) 8253200 B) 8253410 01-7110, 01-7112
Walter Lorenz Surgical, Inc., Also Trading As: Biomet Microfixation Imris Inc. Ceodeux S.A.- Meditec
2011-01-10
2010-10-26 58413
Type II
A) Imris OR Table Model T2X B) Imris OR Table Model ORT100 EZ-OX Plus
2011-01-10 2011-01-10
2010-11-29 59398 2010-12-06 59631
Type II Type III
A) N/A B) N/A M70600055
A) Contact Manufacturer B) Contact Manufacturer All Serial Numbers
EZ-OX Oxygen Regulator
Western/Scott Fetzer Co.
2011-01-10
2010-10-22 59703
Type III
ALQ 1967
All Serial Numbers
Temperature Management System
Cincinnati Sub-Zero Products
2011-01-10
2010-11-29 59357
Type II
233
S/N 061-3-00001 - 101-3-01389
A) RELI SSO HLA-B Typing Kit B) RELI SSO HLA-DRB Typing Kit C) RELI SSO HLA-DQB1 Typing Kit
Invitrogen Ltd.
2011-01-10
2010-12-15 59739
Type III
A) 840.01 B) 810-45 C) 820.01
A) 5661465D, 5844125D, 6671423A, 7013623A, 7146763A, 7550195A, 7604755B, 7800175B B) 6652726B, 6671456B, 7130186B, 7146876B, 7428496C, 7640426F, 7800066E, 7879316H C) 6233005B, 6435925B, 6715065B, 7033115B, 7146895B, 7514185B, 7689765B, 7764665B, 7800025B
Software that has not been validated for diagnostic use has been utilized as the main quality control release testing of the RELI SSO HLA Typing Kits. Upon further investigation, interpretation using the approved manual analysis method has found false positives that may cause a mistyping or no typing result.
A) Cobas Integra System - Acetaminophen B) Roche Hitachi - Acetaminophen
2011-01-10
2010-12-16 59845
Type II
A) 20767174322 B) 03255379190
A) Contact Manufacturer B) Contact Manufacturer
Captia Measles IgM Kit SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent Updated recall #55480 previously posted on 2010-09-13. A) Stellaris Vision Enhancement W/AVS B) Stellaris Vision Enhancement W/AFS C) Stellaris Vision Enhancement-Anterior Deluxe System W/AVS & HSV D) Stellaris Vision Enhancement W/AFS, HSV E) Millenium Microsurgical System-Unit Updated recall #53207 previously posted on 2010-03-29.
Trinity Biotech USA Beckman Coulter, Inc.
2011-01-10 2011-01-10
2010-11-03 59852 2010-06-28 55480
Type II Type II
N/A 467920
019, 020 M812164, M902345, M808240, M810152, M904324, M909608
The manufacturer revised the endogenous claims for the acetaminophen assay on all systems. The limitations-interference section of the acetaminophen package inserts have been updated to indicate the impact of icteric, haemolytic or lipemic samples with low levels of acetaminophen. The quality control criteria for the kit are not met. The results of test runs are invalid. There is no risk of a false positive. Ig-A Reagent lots M812164 and M902345 contain an unidentified cross reacting antibody that may yield falsely high Ig-A results in survey samples for immunoglobulins which are formulated with Ig-M monoclonal antibodies.
Bausch & Lomb Inc.
2011-01-10
2010-02-15 53207
Type III
A) BL11110 B) BL11120 C) BL12110 D) BL12120 E) CX1000BASE, CX3000, CX3000BASE
A) SYS01048, SYS01044, SYS01046, Alert issued on reports of sparking, charring, and fires on power cords reported by Hospira & SYS00921, SYS01065, SYS01037, SYS01097, Abbott Nutrition which are similar to the ones used in Bausch & Lomb products. SYS01128, SYS00931, SYS00896, SYS00983 B) SYS01217, SYS01230, SYS01059, SYS01040 C) SYS00397, SYS00656, SYS00806, SYS00280, SYS00466, SYS00688, SYS00689, SYS00661, SYS00509, SYS00169, & SYS00494 D) SYS00446, SYS00139, SYS00514, SYS00136, SYS00170, SYS00447, SYS00171, SYS00564, SYS00570 E) Contact Manufacturer
A) Acuson Antares System-Main Unit B) Acuson Antares System-Refurbished Unit C) Acuson Antares System-With 5.0 Upgrades Updated recall #53440 previously posted on 2010-03-29.
Siemens Medical Solutions USA, Inc.
2011-01-10
2010-03-02 53440
Type III
A) 5936518 B) 8653771 C) 10032746, 10032747
AMS Advance Male Sling System ETI-MAX 3000 Surgipro Mesh (Multifilament Polypropylene Clear) A) Presice Cryosurgical System B) SeedNet - MRI System
American Medical Systems Inc. Diasorin Inc. Covidien LLC Galil Medical Ltd.
2011-01-24 2011-01-24 2011-01-24 2011-01-24
2010-09-09 56924 2010-01-22 59534 2010-12-16 59843 2010-12-20 59424
Type II Type II Type II Type II
72404224 15950 SPM-35 A) FPRCH2047 B) FPRCH2035
A) 111843, 111922, 111923, 112267, 10134, 111786, 112070, 11092, 10096 B) 111994 C) 114573, 116119, 116146, 115416, 115996, 113510, 116172, 116181, 116198, 116199, 113469, 115300, 114916, 116012, 116015, 115723 615445001 thru 669783001 9163500489 A0K0490 A) PI0051, PI0061 B) N/A
Advisory notice to notify affected customers of a software error encountered after running through the following workflow steps 1) zoom in live image, 2) store a retrospective clip, 3) go to exam review or an offline workstation, and measure the zoomed clip. Measured results may be incorrect with no indication to the user they are wrong.
The results of the tensioning suture tensile testing were not consistent with previous accelerated shelf life testing. Potential failure of the 1000 ul dilutor syringe because of a faulty glue joint. The recall is undertaken due to the potential for the sterile barrier to be compromised. Discovery of damaged optocoupler during preventive maintenance. If optocoupler is damaged and locking mechanism is in an 'unlocked' position the software will not alert of the unlocked status which could result in patient or user injury. Lower than expected R4A / R3 ratios that invalidate the assay when OD R4A / OD R3 falls below 5.00. During packaging validation testing, Olympus found that one of the sealing seams on the sterile package may fail after exposure to external forces in certain simulated handling and shipping conditions. Small holes in the primary pouch of some packaged units constitutes a breach in the package integrity which compromise the product sterility. Functionality issue: when SoftBank history reports for multiple patients were generated using SoftReports. If more than one qualifying patient, each qualified patient has a report, but all orders are listed under each patient, even those that do not belong to them. There is no way to distinguish what results belong to a specific patient.
Platelia Toxo IgG Olympus Pediatric Resection Electrodes
Bio-Rad Olympus Winter & IBE GMBH
2011-01-24 2011-01-24
2010-12-20 59953 2010-12-16 59988
Type II Type II
72840 A37008A, A37009A, A37010A, A37011A, A37012A, A37013A
0D0017, 0D0117 All Lots, Contact Manufacturer
RENASYS Port - Foam Dressing Kit Port SoftBank II v.23.1.2.x, 23.2.0.x,25.0.0
Smith & Nephew Inc. Wound Management Division SCC Soft Computer
2011-01-24 2011-01-24
2010-12-21 59964 2010-06-22 59204
Type II Type II
66800694 N/A
>10 Numbers, Contact Manufacturer 23.1.2.x, 23.2.0.x, 25.0.0.x
Expert DC Intraoral X-Ray System with WallMounting Plate ABL80 FLEX CO-OX System Software 1.30,1.31
Imaging Sciences International, LLC DBA Gendex Dental Systems Radiometer Medical APS
2011-01-24 2011-01-24
2010-12-20 59976 2010-01-07 60032
Type II Type II
110-0207G1 (120 VAC), D800WPEXPERT 393-841
All Lots 302069-70, 302070-72-74-76-79, 302080-81-82, 302092-93-98, 302100, 302140, 302178-79, 302018, 302021, 302023,302025, 302238 >10 Numbers, Contact Manufacturer
The wall-mounting plate is defective and could cause the unit to fall from the wall. If during patient sample measurement, the (THB) parameter is not selected for reporting then any results reported for the fractional hemoglobin parameters (SO2, FO2HB, FCOHB, FMETHB and FHHB) will be values taken from a prior measurement and not associated with the current patient measurement. Drager had been informed about one case in which the neonatal patient was not adequately ventilated in high frequency oscillation (HFO) ventilation mode. The patient desaturated, no permanent patient injury occurred. Investigations have shown that the instability of the mean airway pressure caused insufficient gas exchange resulting in the desaturation of the patient. Advia Chemistry Systems Reagent Blank (RBL) of Advia Chemistry Ethanol_2 Reagent may fail calibration after the reagent has been onboard for 4-5 days, when any of the following reagents Digoxin, ACET, LIP, DHDL, LDL, TBIL_2 and SAL (which contain ethanol) are on board. The Sagittal Blade was determined to potentially have a compromised seal thereby compromising the sterility of the product. There is an increase of "stuck in sheath" reports involving the use of the Super Arrow-Flex Sheath with 5800 S series IAB products. When the IAB becomes stuck in sheath, the user is unable to move the IAB catheter forward and backward, potentially causing a delay in critical therapy. Ethicon is recalling all lots of Ethicon 5mm absorbable strap fixation device due to a potential defect in packaging. This packaging defect could compromise the sterile integrity of the device and/or may cause premature degradation of the absorbable straps. IKARIA is recalling the INOmax DS because it contains an oxygen sensor being recalled by Teledyne instruments. The defect may cause impacted oxygen sensors to lose electrolyte. If one of the INOmax drug-delivery systems contains a defective o2 sensor, the user may observe erratic readings of nitric oxide (NO) during calibration of the system prior to or during use with patients. Because the o2 sensor is housed within the system's monitoring component, rather than the drug-delivery component, delivery of INOmax to the patient is not immediately impacted. Fragments from the pad are disengaging and sticking onto the instrument. This condition could cause fragments to come into contact with the intact cornea prior to surgery. A customer complaint was received for TheraScreen: K-RAS Mutation Kit lot DK 262-01, which confirmed a labelling error with TAQ polymerase, one of the components packaged within the kit. The TheraScreen: K-RAS Mutation Kit lot DK 262-01, is correctly labelled with an expiration date of 27 April 2011, however, the TAQ polymerase (TAQ) packaged within the kit is incorrectly labelled with an expiration date of 28 February 2011. In Artida Ultrasound Systems, under certain conditions the operation panel can become unresponsive (A "lockup"). Beckman Coulter has confirmed that the stability claims for Access Free T4 Calibrator, lot 014769, was not met. Beckman Coulter has confirmed that kit lot 012781,(vial lots: QC1:012778, QC2: 012779, and QC3: 012780) of Access AFP QC may contain a precipitate in all three QC levels included in the kit. Specific lots of the catheter may crack or break during use resulting in the inability to inflate or deflate the balloon and can result in material separation and potential embolization. Beckman Coulter has confirmed that on some systems, water may drip from unused reagent probes during testing on the PK7300 Automated Microplate System. Stryker has become aware that there is a potential for the package of Hydroset to contain 10cc of powder rather than the 5cc labelled on the box.
Ventilation Neonatal Unit
Draeger Medical GMBH
2011-01-24
2010-11-21 60045
Type II
8415000
A) Ethanol 2 Assay B) Ethanol 2 Reagent
Siemens Healthcare Diagnostics Inc.
2011-01-24
2010-12-17 59933
Type III
A) 10379635 B) 10379635
A) 010, 020, 030, 040 B) 010, 020, 030, 040
Sagittal Blade, Fine A) Ultra IAB Catheter Kit B) Percatneous Insertion Tray C) Ultra 8 Intra-Aortic Balloon 5mm Absorbable Strap Fixation Device
Linvatec Corporation D.B.A. ConMed Linvatec Arrow International, Inc.
2011-01-24 2011-01-24
2010-12-10 59971 2010-12-21 60049
Type II Type I
5023-138 A) IAB-05830-U, IAB-05840-U B) IAK-05845 C) IAB-05830-LWS, IAB-05840-LWS STRAP25
180209 A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer CJ6402, CKZ437
Ethicon Inc.
2011-01-24
2010-12-29 60059
Type II
INOmax DS
INO Therapeutics, LLC DBA IKARIA
2011-01-24
2011-01-05 60062
Type II
DS 20050006
Aspen Corneal Marking Pad Sterile
Aspen Surgical Products, Inc.
2011-01-24
2010-12-23 60076
Type III
40490
TheraScreen: K-RAS Mutation Kit
Qiagen Manchester Ltd.
2011-01-24
2010-12-01 59917
Type III
05366259190, KR-41
2010-10-07, 2012-10-12, 2012-11-30, 2012-1215, 2013-04-19, 2013-04-23, 2013-05-21, 201310-01 DK262-01
Aplio Artida Ultrasound System
Toshiba Medical Systems Corporation
2011-01-24
2010-12-13 60048
Type II
SSH-880CV
Access Free T4 Calibrator Access Immunoassay Systems Alpha-Fetoprotein (AFP) QC Kit NanoCross .014" OTW PTA Dilation Catheter Updated recall #59261 previously posted on 2010-12-20.
Beckman Coulter, Inc. Beckman Coulter, Inc.
2011-01-24 2011-01-24
2010-11-29 59633 2010-12-13 59925
Type II Type III
33885 33219
W1B0862082, W1F0982231, W1F0982233, W1F0982235, W1I1092449, WIF0982239, WIF0982240 014769 for Free T4 Calibrator 012781 Access AFP QC Kit
EV3 Inc.
2011-01-24
2010-11-22 59261
Type I
AB14W020080150, AB14W020120150, AB14W025120150
8778807, 8784857, 8811586, 8815410, 9248597, 9416365 A) All Lots B) All Lots IC00874
A) PK7300 Automated Microplate System - Instrument Class 3 Beckman Coulter, Inc. B) PK7300 Automated Microplate System - Instrument Hydroset Injectable Bone Cement Stryker Leibinger GMBH & Co. KG
2011-01-24
2010-11-29 59926
Type II
A) PK7300 B) PK7300 397005
2011-01-24
2010-12-09 59942
Type II
Stratus CS Acute Care Cardiac Troponin-I Testpack
2011-01-24
2010-12-23 60053
Type II
CCTNI
230201002, 230200002, 230242002, 230277002, 230305002, 230319002, 230263002
There is a low frequency of non-repeatable falsely elevated CTNI results without an associated error message. These elevations may cause a sample that would be within the 99th percentile of the reference population, 0.07 ng/ml to read above this value. If this occurs, the CTNI result would be expected to be discordant with the clinical picture, including the classic rise and fall in concentration upon serial sampling. For VMAT plans the QA (measured) dose is lower than Monaco's calculated dose. Overestimation of dose in the treatment field is in the order of 5%. Dual fault failure mode of Engstrom system may occur that can cause patient airway pressures to exceed the user settable PMAX limit.
Monaco RTP System - VMAT Option A) Engstrom Carestation B) Engstrom Carestation - Trolley Options Updated recall # 40775 previously posted on 2009-03-02. A) Coulter Clone & Cyto-Stat/Coulter Clone T11 Monoclonal Antibody B) Cyto-Stat/Coulter Clone T11-RD1/B1-FITC Monoclonal Antibody C) Cyto-Stat/Coulter Clone T11-RD1/B4-FITC Monoclonal Antibody A) IFU for Monopolar Cord B) IFU for Bipolar Cable Verio Magnetom System
Elekta Business Area Software Systems ATA Computerized Medical Systems Inc. Datex-Ohmeda, Inc. DBA GE Healthcare
2011-01-24 2011-01-24
2010-12-30 60326 2008-02-12 40775
Type II Type II
Monaco VMAT A) 1505-9000-000 B) 1505-8538-000
release 2.03 & higher A) >10 Numbers, Contact Manufacturer B) CBCL0047 TO CBCL00453 & CBCL00458
2011-01-24
2010-12-08 59930
Type III
A) 6603849 B) 6603928 C) 6603801
A) 7295004F, 7295005F, 7295006F B) 7252005F, 7252005R, 7252006F, 7252006R C) 7221004F, 7221005F, 7221006F, 7221007F
There was a chance of failure to achieve prepared sample stability claims for CD2-PE values after specimen is prepared with immunoprep reagent system and stored at room temperature for 2 hours.
Stryker Endoscopy
2011-01-24
2010-12-31 60178
Type II
A) 250-040-011 B) 250-040-016 10276755
A) All Lots B) All Lots 40300, 40332, 40366, 40475, 40477, 40508, 40619
Stryker has become aware that the testing from the supplier was missing/inadequate and as a result the units have the potential to fail sterilization validation testing and cleaning validation testing. This update instructions (UI) should help to recognize faulty gradient cable connections and subsequently prevent those from overheating. As part of the UI, thermal sensors (selfadhesive labels) will be attached to the connections identified as critical. If the isocenter location is edited in the IMRT activity, the shift coordinates are not updated in the IMRT plan report. The problem occurs when the isocenter shift coordinates are defined in the sim activity and then edited in the IMRT activity. This recall is an expansion of the December 2010 Codman Disposable Twist Drill recall. Codman has recently identified a packaging problem in certain lots of Codman disposable drills. Cracks have been identified in the sterile package tray in which these products are contained. The product in a cracked package may not be sterile and could result in an increased risk of infection should it be used. Stryker has become aware that sterilization testing performed was inadequate [did not simulate worst case use situations and most challenging sites] and therefore the gravity steam sterilization duration has to be extended in the IFU. Abbott has determined through internal studies, that i-Stat Celite Act Cartridges may exhibit a higher than expected variability in reported results when stored at room temperatures for periods of time in excess of 12 hours. There is no impact to reported results when cartridges are stored refrigerated and warmed to room temperature for use within 12 hours. TomoTherapy has discovered an anomaly during internal testing. If a TomoDirect procedure, which consists of 2 to 12 beam angles, has an unrecoverable interrupt or emergency stop during a short time period between beam angles, there is a small possibility that the procedure will indicate a "performed" status rather than "interrupted" on the operator station. If this occurs the user will not be able to generate a completion procedure. TomoTherapy's investigation revealed that when an unrecoverable interrupt or emergency stop occurs with <1 second remaining in a TomoDirect beam angle, the logic in the software code checks if all the triggers (beam pulses) for the current beam angle is fully delivered and marks the procedure as "performed", rather than interrupted as intended. The anomaly is not taking into account if there are any remaining beam angles to be delivered.
Siemens AG
2011-01-24
2011-01-06 60321
Type III
RTP Software Monaco
Elekta Business Area Software Systems ATA Computerized Medical Systems Inc. Codman & Shurtleff Inc.
2011-01-24
2010-12-30 60327
Type II
Monaco
Release 2.03 & higher
A) Codman Disposable Twist Drill B) Codman Metal Disposable ICP Kit, Adult C) Ghajar Guide Ventriculostomy Kit D) Codman Cranial Hand Drill Updated recall # 59410 previously posted on 2010-12-20. IFU for 33cm Laparoscopic Sterilization Tray
2011-01-24
2010-12-02 59410
Type II
A) 80-1200 B) 80-1190 C) 80-1185 D) 82-6607
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) 421302, 424870, 424871, 427693, 429015, BB235, BB317, KB216, MB219 D) >10 Numbers, Contact Manufacturer All Lots
Stryker Endoscopy
2011-02-07
2010-12-31 60174
Type II
250-015-500
i-STAT Celite Act Cartridges
Abbott Point of Care Inc.
2011-02-07
2010-02-03 60279
Type III
07G01-01, 07G01-02
N/A
TomoTherapy Treatment System - Kit Power
TomoTherapy Incorporated
2011-02-07
2010-12-28 60304
Type II
101264
10332, 10333
Abbott Prism Reaction Trays Liaison N-tact PTH Assay
Abbott Laboratories Diagnostic Division Diasorin Inc.
2011-02-07 2011-02-07
2011-01-06 60323 2011-01-11 60448
Type III Type II
6A36-04 310910
89898M500, 90044M500, 90359M500, 90579M500 All Lots
Abbott has seen an increase in the number of drain time error codes when using Abbott Prism HBSAG and Abbott Prism HIV O Plus Assays with the Abbott Prism Reaction Tray. New reference ranges have been established for the Liaison N-tact PTH Assay using a more detailed reference range study than initially performed when the assay was launched. The introducer tip may detach and embolize during use. Alternately the tip material may elicit a thrombogenic response. There could be a sticky substance on the inside and/or outside of the mask that may manifest itself in approximately 6 to 8 months after manufacturing of the product.
Prelude Short Sheath Introducer A) Oxygen, Aerosol Masks and Face Tents B) Hand Held Medication Nebulizer C) Air Entrainment Masks D) Aerosol Masks E) Aerosol Mask, Power-Mist Medication Nebulizer F) Power-Mist Medication Nebulizer
Merit Medical Systems Inc. Unomedical Inc.
2011-02-07 2011-02-07
2010-12-17 60462 2011-01-07 60125
Type II Type II
PSS-7F-4MT A) 100-E, 102-E, 103-E, 106-E, 107-E, 108-E, 110-E, 200-E, 202-E, 203-E, 3102E, 3104-E, 3224-E, 3226-E, 3230-E, 3266-E, 9102-E, 9106, 9106-E, 9108-E, 9226E, 93102-E, 93226-E B) 953-E C) 120-E, 182-E, 227-E, 245-E, 246-E, 282-E, 3120-E, 3227-E, 9104-E, 9182-E, 9222-E, 93227-E D) 220-E, 222-E E) 228-E, 777-E F) 3773-E, 3776-E, 776-E, 93776-E, 9776-E, 9777-E HA-1-N A) GUTS1000 B) 660005000
H179575 A) >100 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) >100 Numbers, Contact Manufacturer D) >100 Numbers, Contact Manufacturer E) >100 Numbers, Contact Manufacturer F) >100 Numbers, Contact Manufacturer
Inotech Heparin Adsorbant A) General Utility Tray B) HSG Procedure Tray 5F
Connectorate AG Medical Device Technologies, Inc. Also Doing Business As Angiotech
2011-02-07 2011-02-07
2011-01-21 60454 2010-12-28 60042
Type II Type II
N/A A) 010220EO, 010220E0, 010320G0, 013120Y1, 028723JE, 82521PQA, 81631NZT B) 00391Z97, 009620AK, 021422A7, 82341PEQ, 90261S5R, 91411UKV, 92721X4R M102081, M102082, M102083, M10208
Inotech Heparin Adsorbant is being recalled because it is an unlicenced device that was sold to healthcare facilities in Canada. The sterile barrier of the packaging may be compromised.
i-Stat Cardiac Marker Control Levels 1, 2, 3 and Calibration Verification
2011-02-07
2010-12-29 60280
Type III
06F12-02, 06F13-02, 06F14-02, 06F15-02
It was found that there was a higher than expected rate of values from control level 1 and calibration verification level 1 that were outside of the value assignment sheet (VAS) limits. Internal studies have determined that the presence of co2 in the head space of the vial is the cause of high results. Venting the gas in the head space of the vial to remove any co2 that may be present prior to the thawing of the material has been shown to prevent the occurrence of high results. The pack may contain drills of a smaller size than indicated by the label. Failure of the o2 sensor leading to the occurrence of a calibration failure of the o2 sensor within the EPGS of the System 1.
GT Drills Advanced Perfusion System 1
Dentsply Tulsa Dental Specialties Trading as Dentsply Endodontics Termo Cardiovascular Systems Corp.
2011-02-07 2011-02-07
2010-12-23 60309 2010-08-12 56245
Type III Type II
GTS3DC 801763
5051208 1-1340
Infus O.R. Syringe Pump
Baxter Healthcare Corporation
2011-02-07
2011-01-11 60650
Type III
2L3100, 6461500
Baxter Corporation is providing notification that over-the-counter Energizer C size alkaline batteries should not be used with Infus O.R. Syringe Pumps. This particular battery incorporates a feature that may inhibit electrical contact and may affect the ability of the pump to power up. COULTER LYSE S III diff Lytic Reagent lot number 101554F was released for distribution to customers prior to completion of QC testing. The material failed QC testing for hemoglobin (HGB) and white blood cells (WBC). The return line air detector is being added as a precautionary measure because the manufacturer has received reports where excessive clotting (incident rate 0.009%) in the extracorporeal circuit resulted in air entering the return line. Data within printed reports obtained from the Latitude Server since June 6, 2010 may not be accurate. Specifically, when printing reports for more than one patient at a time, the most recent presenting electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect. Smiths Medical has become aware of an increased trend in reports of the cassette lock mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoir (or administration set). The purpose of the cassette lock is to secure the medication cassette reservoir (or administration set) to the pump. The bolts used to fasten the counterweight to the gantry, may not, in some cases be fully tightened to the required torque specification. In the worst possible scenario (which has never occurred) this could result in the counterweight detaching from the gantry. Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that multiple isocenters are present. Acquired couch parameters can be applied to any or all fields in the treatment plan regardless of isocenter definition. This involves product versions 7.029, 8.1.1.3, 8.1.3,8.1.4.0, 8.3.0.12, 8.6.1, 8.6.2.0, 8.8.1.7. This letter is to notify you that we have determined that there is an error in the estimation of mean pressure gradient in the cardiac measurement package available on all versions of Acuson X300 Ultrasound Systems. Dimension Clinical Chemistry System creatinine (CREA) flex reagent cartridges have the potential for falsely elevated creatinine results for quality control and patient samples. Edwards Lifesciences is recalling the EP and SCS01 Coronary Sinus Catheters due to possible hemostasis valve displacement of the INTROCSC introducer component contained in packages of these products. If the valve becomes displaced there is an unlikely chance that the valve could be pushed through the sheath. Conmed has determined there is a chance that a sequence of events may lead to a situation in which there may be leakage of electrical energy to the user or unintended dispersive path for the patient if the unit is activated and could result in an electrical burn. A report received to-date indicates that the ink used to make the butterfly pattern on the cap may come off in a form of tiny blue particles. This may pose a safety risk. Edwards Lifesciences is issuing a field safety notice to augment the instructions for use (IFU) of the device to reinforce the correct preparation, orientation and hydration of the transcatheter heart valve (THV) when it is loaded onto the Ascendra 2 Delivery System. Edwards Lifesciences has become aware that loading at an angle (ie non-coaxial) may unseat the valve within the loader, creating a leak path at the seal button. When the valve in the loader is hydrated per the IFU this leakage is likely to be detected before use. If observed, leakage can be easily resolved by manipulation of the seal buttons. Lorsque la vanne dans le chargeur est hydrate selon la NDI, cette fuite pourrait probablement tre dtecte avant lutilisation. Les fuites peuvent tre facilement rsolues en manipulant les boutons de fixation si elles sont dceles. The Greenlight II Laryngoscope Handle with a top window battery cartridge may not function correctly. If the handle is subjected to a force perpendicular to the long axis of the handle, a battery may shift in the cartridge. This could result in an intermittent light source or loss of light source. Product labelled Endopore Implant, 01B-7L1, with 1mm collar, actually contains 2mm collar. No safety/efficacy issues since collar is the same length and osteotomy is the same size. CareFusion is aware of three significant events involving Alaris Syringe Pumps administering into a high negative (vacuum) pressure patient line which resulted in a bolus. This condition may exist where the infusion line is shared with other high pressure medical pumps such as extracorporeal blood pumps, dialysis pumps, cardiopulmonary bypass pumps, or haemodialysis pumps. Thomas Medical Products has recently become aware that in some instances the pouch seal that maintains the sterility of the product may be weak or open and compromise the sterile barrier. The TAQ polymerase is not amplifying DNA as intended. There is suspected contamination that is causing the TAQ to not work properly. Kits which contain the affected lot of TAQ (TAQ polymerase vial lot # 864459) are not useable unless a different lot of TAQ is used. Users have replaced keyboards supplied or approved by Philips with multi-media-type keyboards which have an audio volume adjustment and muting controls. This allows users to easily mute audio alarms on the Intellivue Information Center or to reduce their volume. The alarm audio volume on bedside monitors and client devices connected to the Intellivue Information Center is not affected. Although the service and installation guide includes warnings about the use of hardware and software not supplied by Philips, it does not specify that ignoring the warning can result in loss of alarm annunciation or in the impairment of central patient monitoring. If 80 KVP is selected for a low dose CT on a Gemini 64 PET/CT, during the PET acquisition the concurrent reconstruction will fail and the customer may think that their images were lost. This may cause the customer to re-scan the patient. Smith & Nephew has found that specific lots of the cannulated reusable obturator will not fit the disposable Clear-Trac cannula identified for use with the product.
COULTER LYSE S III diff Lytic Reagent
2011-02-07
2010-12-27 60297
Type II
6605523, 6605526, 6605360, 723585, 6605632, 178833, 6605122, 6603208
Lytic Reagent 101554F
Spectra Optia Apheresis System
CaridianBCT, Inc.
2011-02-07
2010-12-13 60324
Type II
61000
1P00100-1P00719
Latitude Secure Server
Cardiac Pacemakers Incorporated
2011-02-07
2011-01-10 60523
Type III
6441
N/A
A) CADD-Solis Ambulatory Infusion Pump B) CADD-Solis VIP Ambulatory Infusion Pump
Smiths Medical ASD, Inc.
2011-02-07
2011-01-14 60660
Type II
A) 21-2101-0200-02, 21-2101-51, 21-2102-51, 21-2111-0100-51 B) 21-2120-0100-50
A) >100 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer
A) Clinac Linear Accelerator B) Clinac IX Radio Therapy Delivery System
Varian Medical Systems, Inc.
2011-02-07
2010-12-10 60671
Type II
A) 2100C, 2100C/D B) Clinac IX
Aria Practice Management - 4D Integrated Treatment Console (4DITC)
2011-02-07
2010-12-14 60672
Type II
V8.1.2, V8.6, V8.8
Acuson X300
Siemens Medical Solutions USA, Inc.
2011-02-07
2011-01-12 60723
Type III
10348531
315605
Dimension Clinical Chemistry System
2011-02-07
2010-12-28 60301
Type III
DF33A, 10444968
CA1260, BB1268
A) Endoplege Coronary Sinus Catheter, Model EP B) Steerable Coronary Sinus Catheter, Model SCS01
Edwards Lifesciences
2011-02-07
2010-12-03 60295
Type II
A) EP B) SCS01
A) >10 Numbers, Contact Manufacturer B) 666556, 669235, 678238, 751043, 755821, 763122 >10 Numbers, Contact Manufacturer
System 2450 120V
Conmed Corporation
2011-02-07
2011-01-10 60798
Type II
60-2450-120
Bouffant Caps Ascendra 2 Delivery System
Trudell Medical Marketing Limited Edwards Lifesciences LLC
2011-02-07 2011-02-07
2010-08-25 56406 2011-01-04 60740
Type III Type II
T16199400DFL 9320AS23, 9320AS26
100315 N/A
Greenlight II Laryngoscope Handle & Blade
Vital Signs Inc.
2011-02-07
2011-01-12 60808
Type II
4558GSP
Endore Implant
Ormco Corporation Also Trading as Sybron Implant Solutions CareFusion Switzerland 317 Srl
2011-02-07
2010-12-29 59634
Type III
01B-7L1
Sept. 2009 - Nov. 2010
A) Alaris PK Syringe Pump B) Alaris CC Syringe Pump C) Alaris Tiva Syringe Pump D) Alaris GH Syringe Pump Transvascular Insertion Tool
2011-02-07
2011-01-13 60718
Type II
A) 80053UN01 B) 80033UND1 C) 80043UN01 D) 80023UN01 TVI-07
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer S32830, S33028
Thomas Medical Products, a GE Healthcare Company Invitrogen Corporation
2011-02-21
2010-12-23 60649
Type II
Invitrogen ABC UniTray with TAQ
2011-02-21
2011-01-17 60792
Type III
78001-10
037 851612/883129
A) Agilent-Information Center B) Agilent-Information Center Client C) Intellivue-Information Center Client D) Intellivue-Information Center E) Intellivue-Database Server F) Intellivue-Patient Link Documentation Center
2011-02-21
2010-11-25 60741
Type II
A) M3150A B) M3153A C) M3151B D) M3140, M3145, M3150, M3155 E) M3154 F) M3170
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer
Gemini TF 64 PET/CT System - PET Subsystem
2011-02-21
2011-01-14 60742
Type II
4535 679 81361
N/A
Clear-Trac Flexible Reusable Obturators
Smith & Nephew, Inc., Endoscopy Division
2011-02-21
2011-01-13 60801
Type III
72200899, 72200900, 72201796
Cysto-Care Urological Procedure Trays
Coloplast A/S
2011-02-21
2011-01-27 61091
Type II
N/A
A) HMX Hematology Analyzer B) Coulter MAXM Hematology Analyzer C) Coulter MAXM Hematology Analyzer with Autoloader and Reticulocyte Synchron Systems Multi-Calibrator
2011-02-21
2010-12-13 59923
Type II
A) 6605523, 6605526 B) 6605122 C) 6603208 442600
A) All Lots B) All Lots C) All Lots For Multi-Calibrator M805618, M907396
2011-02-21
2010-12-13 59928
Type III
A) Precedence System - 16 Slice B) Precedence System - 6 Slice C) Skylight Gamma Camera System
2011-02-21
2011-01-14 60743
Type II
A) 2169-3000A B) 2169-3002A C) 2160-3000A, 2160-3000B, 2161-3000B, 2161-3001B
A) N/A B) N/A C) N/A
Lexicon K Files Labelled as Lexicon C Files
Dentsply Tulsa Dental Specialties Trading as Dentsply Endodontics Med-Tec Inc. DBA Civco Medical Solutions
2011-02-21
2011-01-17 61001
Type III
CF01025
1007002395
These procedural trays contain a sterile pack of lubricant and/or an alcohol prep pad which are manufactured by Triad Group and are currently under a recall because of contamination concerns. Beckman Coulter has confirmed that the MAXM, MAXM AL, HMX and HMX AL analyzers omit the tilde (~) character when the tilde is used as part of the sample id within a barcode label scanned by the primary mode barcode reader. As an example, '123~456' would result as '123456' with the tilde character omitted. Beckman Coulter Inc., has confirmed that triglycerides (TG) results may recover lower than expected values when using the Synchron Multi-Calibrator (Multical), lot numbers: M805618 and M907396. Philips has recently become aware of collisions and excessive force exerted on the lower portion of the detector arms of Precedence and Skylight Spect systems which many have resulted in the detector arms breaking. A collision or excessive force may lead to a crack or fracture in the upper portion of the arm, which may cause the detector arms to break and the arm and detector to fall. The pack may contain drills of a different type and a smaller size than indicated by the label. The Lexicon K Files have been labelled as Lexicon C Files. Some versions of the Body Pro-Lock SBRT Systems (platforms) have different lateral platform position scale markers. Also affects platforms in systems MTSBRT001 ABD MTSBRT001L. Unlicensed class II medical device, Sanvic Pulsatile Nasal Irrigator. The Synchron Glucose (GLU) cartridge assay, being used in Synchron systems, did not accurately measure glucose in some urine samples, resulting in a positive bias. Beckman Coulter has confirmed that the COULTER PrepPlus2 failed to sense that there was no or low volume of reagent in the vial. When this occurred, no reagent or insufficient volume of reagent was dispensed into daughter tubes and operator was not alerted. Ortho Clinical Diagnostics has identified a software anomaly that can occur with analyzers connected to the bypass modules listed on an enGen Laboratory Automation System using TCAutomation software version 3.1.1 and below. When this anomaly occurs, it is possible for a sample other than the intended sample to be aspirated, potentially leading to test results being assigned to the wrong patient without error notification. Synergy users may occasionally experience "RTD out of range" alarms and/or aborted cycles due to temperature reading errors caused by an integrated circuit (IC) chip on the printed circuit board in the units. Medline Industries was alerted by Triad Group that a recall was being initiated. It has been initiated due to concerns expressed by the FDA regarding the product. The recall is being initiated because use of inadequately sterilized product might result in patient infection.
Body Pro-Lok Platform
2011-02-21
2011-01-05 61069
Type III
N/A
Sanvic Pulsatile Nasal Irrigator Sychron Systems Glucose Reagent (GLU) COULTER PrepPlus 2
Yiin Wang Industrial Co. Ltd. Beckman Coulter, Inc. Beckman Coulter, Inc.
2011-02-21 2011-02-21 2011-02-21
2011-01-14 61012 2010-08-09 56166 2011-01-17 61029
Type III Type III Type II
SH953 442640 378600
N/A All Lots All Lots
enGen Laboratory Automation Systems
Thermo Fisher Scientific OY
2011-02-21
2011-01-28 61214
Type II
enGen
J16XQH4J, JCT20Q3J
Reliance Synergy Washer/Disinfector
Steris Canada Corporation
2011-02-21
2010-10-29 58918
Type III
FH03072
3612510004, 3612410008
A) Lubricating Jelly B) Necessaire A Catherisme Foley C) Sterile Universal Foley Insertion Trays D) Sterile Urethral Catherization Tray E) Harmonized Laparoscopic Gynecology Pack F) Hydterectomy Pack G) Harmonized Gyne Peri Pack H) Abdominal Aorta Pack I) Open Heart Pack J) Prostatetomy Pack K) C-Section CDS Pack L) Minor Cysto Pack M) Major Cysto Pack N) Gen Urology Minor O) Harmonized Cystoscopy Pack P) Harmonized TUR-LF Pack Q) Harmonized Major MIS Lithotomy Pack R) Harmonized Major Universal LF Pack
Medline Industries Inc.
2011-02-21
2011-01-10 60710
Type II
A) M199110B B) M102108X, M102116B, M102124B, M102124T, M102133X, M102136X, M102144X, M102145A, M102147X, M102148X, M102149X, M102150X, M102151X, M102225X, M102231X, M102270X, M102277A, M102277X C) DYNDCA10160, DYNDCA18100, M102152X, M102284X, M102285X D) M102140X, M102142X, M102143X, M102219X, M102245X, M102256X, M102267X, M102271X, M102273X, M102278X, M102282X E) DYNJ33325X F) DYNJ33243X G) DYNJ34958X H) DYNJ33021X, DYNJ33316X I) DYNJ33025X J) DYNJ33019X K) CDS982078X L) DYNJ34384X M) DYNJ34385X N) DYNJ34457X O) DYNJ33333X P) DYNJ34959X Q) DYNJ34955X R) DYNJ34957X
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer G) >10 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer J) >10 Numbers, Contact Manufacturer K) >10 Numbers, Contact Manufacturer L) >10 Numbers, Contact Manufacturer M) >10 Numbers, Contact Manufacturer N) >10 Numbers, Contact Manufacturer O) >10 Numbers, Contact Manufacturer P) >10 Numbers, Contact Manufacturer Q) >10 Numbers, Contact Manufacturer R) >10 Numbers, Contact Manufacturer
StealthStation S7 - Cart
Medtronic Navigation, Inc.
2011-02-21
2011-01-11 60744
Type III
9733856
4501254366
Some navigation cameras manufactured between September and October 2010 may have a faulty electronic component that can cause the camera to stop tracking instruments or track instruments inaccurately. Recall initiated due to a potential of these draining bags to leak during patient use. CareFusion is aware of three significant events involving Alaris Syringe Pumps administering into a high negative (vacuum) pressure patient line which resulted in a bolus. This condition may exist where the infusion line is shared with other high pressure medical cardiopulmonary bypass pumps, or haemodialysis pumps. It is possible that XVI will not acquire data for a small section at the start and stop angles of the flexmap acquisition. This can cause an error: isocenter displacement with 2D planarview images acquired at +/- 180 degrees. McKesson has identified a rare scenario where the system's monitoring mechanism might initiate a system restart during a clinical procedure. As a result, a labelling update is initiated. Intubation hoops utilized in the manufacture of the HR-IM Intubation Head Ring assembly have been produced with excess material beyond the pivot drill hole. When pivoting the intubation hoop into the down position this excess material can come in contact with mating accessories making it impossible to (A) pivot the hoop into its final downward position or (B) prevent the accessories from being fully seated into the head ring assembly. Potential situation for occurrence of non mono flags on the Cobas Integra Platform when calibrating with the tinaquant soluble Transferrin Receptor assay for identified lots. Therakos has received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits.
Remington Medical 600-D Drainage Bag A) Alaris PK Syringe Pump B) Alaris CC Syringe Pump C) Alaris Tiva Syringe Pump D) Alaris GH Syringe Pump A) XVI X-Ray Volume Imaging System B) XVI R4.5 X-Ray Volume Imaging System Horizon Cardiology Hemo System
Remington Medical, Inc. CareFusion Switzerland 317 Srl
2011-02-21 2011-02-21
2011-01-18 61102 2010-12-10 60718
Type III Type II
Elekta Limited
2011-02-21
2011-01-05 60902
Type II
600-D A) 80053UN01 B) 80033UND1 C) 80043UN01 D) 80023UN01 A) MRT9451 B) MRT 13221 HCH-200
083302 A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer A) V.- 4.2, V.- 4.2.1 B) V.- 4.5 >10 Numbers, Contact Manufacturer
McKesson Medical Imaging Company
2011-02-21
2010-11-02 61031
Type III
CRW System - Intubation Head Ring Kit
Integra Radionics, Inc.
2011-02-21
2011-01-12 61135
Type III
HRAIM
0189463
Cobas Integra S Transferrin Recept 80T Therakos UVAR XTS Procedural Kits
Roche Diagnostics GMBH Therakos, Inc.
2011-02-21 2011-02-21
2010-09-09 61312 2011-02-01 61343
Type III Type II
20763454122 XT125
62903801, 63306101, 63601901 >10 Numbers, Contact Manufacturer
A) OneTouch Diabetes Management Software (v.2.3.2 & LifeScan Inc. 2.3.3) and meter driver V.1.10 B) OneTouch Zoom Pro Diabetes Management Software V.5.1 A) Carescape Monitor B850 System -C1 CPU GE Medical Systems Information Technologies, B) Carescape Monitor B850 System - C1 CPU with third video Inc. QUANTA Lite ANA ELISA Reliance Endoscope Processor Cholangioscopy Access Balloon A) Kodak DirectView CR 850 System B) Kodak DirectView CR 950 System Inova Diagnostics Inc. Steris Canada Corporation Wilson-Cook Medical, Inc. Carestream Health, Inc.
2011-02-21
2011-01-31 61356
Type III
A) 021-349, 022-150 B) 022-151
A) A-51841, A-58777, A-58278 B) A-58277
OneTouch Ping Meter Remote (with colour screen) does not operate properly with OneTouch Diabetes Management Software or OneTouch Zoom Pro Diabetes Management Software. This issue does not affect any other compatible devices with the software, it is limited to OneTouch Ping Meter Remote with colour screen only. Numerous different problems under specific conditions associated with the CARESCAPE Monitor B850. The HRP stop solution (cat 508509) a component of the kit was labelled with an incorrect expiry date. The Reliance EPS experiences internal water leaks, interrupted cycles or nuisance fault alarms even though no actual fault condition exists. Product has been associated with complications including air embolism and gastro-intestinal perforation with no direct failure of the device. The Directview CR version 5.4 software used with the 24 x 30 cm type GP/PQ or HR cassettes creates an image size which is 16 % smaller than true size. As a result images smaller than true size will be printed, or displayed to the CR user interface or PACS workstation. This will only occur when the true size option is selected within the image editing menu. Other uses are not impacted. Even when a patient result fails a validation rule programmed into the assay, the quantitative result (calculated value) will still be reported in the PHD worklist results and be transmitted to the LIS (laboratory integrated system) if the user chooses to send the results. The Triad Sterile Lube Jelly component recall has been initiated due to concerns expressed by FDA regarding the validation of the gamma radiation sterilization cycles for these products. Cardinal Health Canada couriered a recall notification to affected customers on January 28, 2011.
2011-02-21
2011-01-14 59088
Type II
A) 2020913-002 B) 2020913-003 708750 MB000078, MB3001, MB3002, MB310447, MB310448 DPOC-15 A) 854-7275 B) 132-7238
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer N/A 3629002004 to 3616710006 W2889216, W2910395 A) 3152, 3013, 3137, 3146, 3147, 3148, 3144, 3150, 3104 B) 3030, 3031, 3033
2011-02-21 2011-02-21 2011-02-21 2011-02-21
2011-01-21 61006 2010-12-22 61309 2011-01-14 60725 2010-11-24 61257
Type III Type III Type II Type II
System PHD EIA/IFA - Software
Bio-Rad Laboratories Diagnostics Group
2011-02-21
2011-01-31 61332
Type II
4260246
AA00998-2.2, AA62587, AA70776-2.0A, AA91575-2.1A, BA70776-2.0A, BA91575-2.1A, BA90235, CA90235

A) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant B) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant C) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant D) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant E) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant F) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant G) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant H) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant I) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant J) >10 Numbers, Contact Manufacturer K) >10 Numbers, Contact Manufacturer L) >10 Numbers, Contact Manufacturer M) >10 Numbers, Contact Manufacturer N) >10 Numbers, Contact Manufacturer / O) >10 Numbers, Contact Manufacturer / P) >10 Numbers, Contact Manufacturer / Q) >10 Numbers, Contact Manufacturer R) >10 Numbers, Contact Manufacturer S) >10 Numbers, Contact Manufacturer T) >10 Numbers, Contact Manufacturer / U) >10 Numbers, Contact Manufacturer / V) >10 Numbers, Contact Manufacturer / W) >10 Numbers, Contact Manufacturer X) >10 Numbers, Contact Manufacturer Y) >10 Numbers, Contact Manufacturer / Z) >10 Numbers, Contact Manufacturer AA) >10 Numbers, Contact Manufacturer
A) Custom Sterile Cystoscopy Pack B) Custom Sterile ABDOM Hysterectomy Pack C) Custom Bowel Resection-Lithotomy Pack D) Custom Sterile Pacemaker E) Custom Sterile Bowel Resection Pack F) Custom Sterile FEM POP Pack G) Custom Sterile Urology Pack H) General Surgery Pack I) Custom Sterile Extremity Pack J) Custom Sterile-Sterile Large LAP Pack K) Laparoscopy Packs L) Sterile T.U.R.P. Pack M) Custom Sterile Kidney Pack N) Custom General Gastro-Urology Packs O) Custom Sterile Craniotomy Pack P) Custom Sterile Dental Pack Q) Custom Sterile General GYNE Pack R) Custom Sterile Hysterectomy Packs S) Custom Sterile Labour & Delivery Pack T) Breast Packs U) Laparatomy/Laparoscopy Pack V) Vascular Pack W) Aorta/Aneurysm Pack X) By-Pass Pack Y) General Cardiovascular Pack Z) Abdominal Packs AA) Custom Sterile Right Colectomy Pack HC2 System Software ver. 3.0, Suite 4.0
Cardinal Health
2011-02-21
2011-01-26 61358
Type II
Qiagen Gaithersburg, Inc.
2011-02-21
2011-01-12 61369
Type II
A) SBA30CPXXX, SOT30CYXXX B) SMA30AHXXX C) SBA30BLXXX D) SAN30PIXXX E) SOT30BA'XXX' F) SCV30FPXXX G) SBA30MU'XXX', SBA30UGXXX, SBA30URXXX, SOT30VAXXX H) SBA30RBXXX, SBA30TVXXX, SUT30CAXXX I) SOP30OSXXX J) SBA30LL'XXX' K) SLC30DV'XXX' L) SBA30CYXXX, SBA30RPXXX, SBA30TPXXX, SBA30TUXXX, SOT30PRXXX, SOT30RPXXX M) SBA30DN'XXX' N) SBA30UPXXX O) SNE30CRXXX P) SEN30MJXXX Q) SMA30DL'XXX', SMA30PNXXX, SMA30VHXXX, SMA30VLXXX R) SMA30HVXXX, SMA30HYXXX S) SMA30BIXXX, SMA30CSXXX T) SAN30BD'XXX' U) SLC30LPXXX, SMA30LAXXX V) SCV30VAXXX W) SBA30AAXXX, SCV30DD'XXX' X) SCV40OHXXX Y) SCV30LOXXX Z) SBA30ABXXX, SBA30RE'XXX' AA) SBA30CD'XXX' 5050-00162, 5050-11140A, 5050-11240A, 5050-20000A
N/A
There is a software defect relating to the use of the edit function on plates running two digene HC2 assays on the same 96-well microplate. When an edit is made to a specimen identifier associated with second assay protocol on the plate, an error occurs that causes the edited patient specimen identifier to become associated with an incorrect digene microplate luminometer reading. This recall is due to a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Trumpf has received two customer reports of the leg section of the table articulating without prompting from the user. According to these reports and the analysis conducted thus far, this independent movement can occur without particular circumstance or condition. Initial findings have led Trumpf to assume for the safety of patients and users that unintended movement could occur on any version of Titan without notice. 1. Erroneous measurements on CT images identified. 2. Possibility of getting wrong standardized uptake values (SUV) 3. Software issue in brain spect application may switch between display of early and late images of dual scan studies. Some of this product has failed to successfully complete instrument setup. The instrument setup required an additional tube of 7 color setup beads to be completed. The cursor on the dialysis screen may disappear and not respond to user input. This failure is a consequence of discharge of electrostatic charge from the touchpad. Recall initiated following an alert from Triad Group regarding potential problem with sterilization that could result in patient infection.
Cement Restrictor, Size 3
Depuy Orthopaedics, Inc.
2011-02-21
2011-02-03 61458
Type II
546014000
ET5EA4
Titan Surgical Table
Trumpf Medizin Systems GMBH & Co. KG
2011-02-21
2011-02-01 61460
Type II
1228073
All Lots
A) Xeleris 2 Workstation Imaging System B) Xeleris Nuclear Medicine Workstation C) Xeleris 3 Workstation Imaging System BD FACS 7 Color Setup Beads Fresenius 2008T Hemodialysis System
GE Medical Systems Israel, Functional Imaging
2011-03-07
2011-01-19 59982
Type II
A) H3900JH, H3900NM, S8006KA/KB/KC/KD B) H3700JA/JB/KA/KB C) XELERIS 3 335775 190713
Becton, Dickinson and Company BD Biosciences Fresenius USA, Inc.
2011-03-07 2011-03-07
2011-01-10 60724 2011-01-19 60933
Type III Type III
A) >100 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) 0000CZC94158R3000, 0000CZC94154WH002 83284, 87471 >100 Numbers, Contact Manufacturer
A) Lubricating Jelly B) Urethral Catheterization Tray Vesical C) Probe Installation Kit-Bladder Syringe A) Orbit 90 Subcutaneous Infusion Set B) Orbit Micro Subcutaneous Infusion Set
Omega Medical Products
2011-03-07
2011-01-11 61042
Type II
ICU Medical Inc.
2011-03-07
2011-01-25 61376
Type I
A) 10-8472, LG-105 B) NIS-001, NIS-278, NIS-382, NIS-5006, NIV-001 C) NIS-001, NIS-039, NIS-067, NIS-088, NIS-090, NIS-382, NIS-440, NIV-001, PAC-141 A) M1861, M2461, M2491, M309, M4261, M4291, P1861, P189, P2461, P2491, P3061, P309, P4261, P4291 B) P1851, P1881, P2451, P248, P3051, P3081, P4251, P428 Discovery-W, Discovery-WI
A) >100 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) >100 Numbers, Contact Manufacturer A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer
Discovery QDR Bone Densitometer with Frax Software Tool
Hologic, Inc.
2011-03-07
2011-01-25 61282
Type II
85130, 85025, 85091, 84963, 85123
PleurX Drainage Kits
CareFusion Corporation
2011-03-07
2011-01-31 61459
Type II
50-7500B, 50-7510
All lots
Continuation of the Triad alcohol wipe recall. Product is co-packaged with the Orbit 90 Subcutaneous Infusion Pump (device identifier # 228516) and the Orbit Micro Subcutaneous Infusion Set (device identifier #538766). Recall is due to concerns about potential contamination of the Triad Group's products with the bacteria, bacillus cereus. The Frax software tool associated with some Discovery W and Discovery WI QDR series bone densitometer systems is being recalled because it is not approved for distribution in Canada. CareFusion was notified by Triad Group of a recall of alcohol prep pads which are included in the PleurX Kits. The recall of the alcohol pads is due to concern over possible contamination.
A) Symbiq One Channel Infuser B) Symbiq Two Channel Infuser Updated recall # 54403 previously posted on 2010-10-11.
Hospira Inc.
2011-03-07
2010-04-26 54403
Type I
A) 16026 B) 16027
1- Increase frequency of white screen alarm code S006/S308/S408. 2- Potential of unrestricted flow when set is removed from the pump. Moreover, the check flow stop alarm intended to warn users of free flow conditions may not consistently operate as intended and may not reliably provide appropriate warning. 3- Reports of Symbiq Pump not detecting air in line. NuMED Canada, Inc. incorrectly labelled and shipped product. Two lots have been inadvertently switched and incorrectly labelled and shipped. Ethicon, Inc. is voluntarily recalling multiple lots of Dermabond Topical Skin Adhesive based on reports that some units contained discoloured product in the vial, and may also have had prolonged setting times. Wires coming loose on the washer terminal box cause the motor overload to trip and to overheat and melt. On some masks, there could be a sticky substance on the inside and/or outside of the mask that may manifest itself approximately 6 to 8 months after manufacture of the product. The sticky masks could result in inconvenience and, in some cases, there is a remote possibility of potential harm to patient. When scanning with imaging preset of fetal heart, pediatric heart, adult heart or coronary in certain software versions of Aplio XG and Xario XG, the patient-contact surface of transducer PST-65AT may become abnormally hot when a different imaging preset is selected during the same study. This is a software issue. Beckman Coulter has confirmed that the lot numbers 992721 and 992809 for the ACTIVE Inhibin A ELISA may not meet the stated analytical sensitivity of 1.0pg/ml. Due to a packaging error, Quidel has estimated that a small number (approximately 3) of hCG kit boxes were packed with incorrect test cassettes. These incorrect tests were h. pylori test cassettes. Two reports have been received that the driver handle of the 5.5 mm CrossFt Suture Anchor has the incorrect colour. It should be black but is red. When the user presses the tilt buttons on the opti grip hard deep at the lower end of the button, the button can become stuck under the housing. This may lead to unintended continuous tilt movement of the system, with potential hazard to the patient. Possibility that loose granules may enter the inspiratory path of the breathing system. This applies only to GE-ADU and Anmedic Q systems anaesthesia machines. Edwards Lifesciences discovered that the flow rate of this device was incorrectly stated on the box (case) label as 3 ml/hr, but was correctly stated on the unit pouch label as 30 ml/hr. This error was limited to the two lots stated. These Lite Wands were originally classified as class I, however, upon discussion with Health Canada, it was determined that this device could be exposed to fat and blood and is therefore considered invasive and should therefore be considered a class II device. Under certain conditions the EtCO2 values and ventilation rate values can display interchangeably (unexpectedly or random switch) either under the ventilation rate label or the EtCO2 label. Conmed has received complaints of cervical cup or uterine balloon detachment for the VCare vaginal-cervical ahluwalia's retractor-elevators manufactured after April 11, 2008, which may be related to user technique. A metal component within the unit can break and cause a malfunction. Use of this product may represent a potential health hazard if the metal component is not removed after breakage. This update instruction provides details for the exchange of the detector holder. A certain serial number band of detector holders has weak welded seams. To avoid future breaking of the detector holder's arm the affected detector holders will be exchanged. A behavior seen with Varian Treatment (VT) software when either connected to a Siemens Linear Accelerator using Digital Mevatron Interface Protocols (DMIP) 5 or 6 in delivery of a conventional or IMRT plan with more than one field and/or when VT is installed with the couch value propagation feature. The user may not be aware that couch rotation values were updated for all user selected fields following the use of the couch value propagation feature. Customer complaints have been received for an error in the maximum on-board stability time displayed on the Architect when using lot 01110L000. Upon loading a new kit of lot 01110L000 onto the Architect and scanning the barcode, the kit displays an incorrect on board stability of 1680 hours, which would equal 70 days. The correct on board stability time is 168 hours, which would equal 7 days. The reagent package insert (commodity 492152/R1) states in the storage instructions section, "the Architect 25-OH Vitamin D 100-test reagent kit may be stored on board the Architect I system for a maximum of 7 days." The conversion of 7 days into hours is 168 hours. Since October 28, 2010 FMCNA-RTG has received reports of 19 incidents of internal blood leaks for Optiflux F250NRe Hemodialyzer lot 10HU02012. Quality trending analysis has revealed that lot 10HU02012 demonstrated a higher blood leak rate than for lots proceeding and following lot 10HU02012. Same thing for the lot 10LU2016.t faite dans le cas du lot 10LU2016. Complaint received that set time for Maxcem Elite was too short. Therefore when restoration was placed on tooth it would not adhere properly. Packaging error. 6-pack of Soft-Core Classic size #30 verifier incorrectly packaged with 6pack of size #25 obturator. Labeling error OptiBond FL Adhesive Refill autobags actually contains OptiBond FL Primer bottle. Various AC and/or DC power source issues such as: no AC operating power and/or no DC operating power. The new moulded canister lids(gray lids) for the UniCel DxC 800 could crack over time causing pressure and vacuum error.
A) Z-Med II B) Coefficient PTV Catheter Dermabond Topical Skin Adhesive
NuMED Canada, Inc. Ethicon LLC
2011-03-07 2011-03-07
2011-02-03 61435 2011-02-07 61530
Type II Type III
A) PDZ611 B) COE125 AHV12, AHVM12
A) JZ-7536 B) JC-0563 CJP841, CKE811, CKE512
Reliance Synergy Washer/Disinfector
Steris Canada Corporation
2011-03-07
2011-01-03 61593
Type III
FH03053
Portex First Breath Oxygen Masks
Smiths Medical ASD Inc.
2011-03-07
2011-02-10 61612
Type II
002610
3622708005, 3606008002, 3632407010, 3629507005, 3621807006, 3617707008, 3631808004, 3622907004 09-50
A) Xario XG - Main Unit B) Aplio XG Ultrasound System - Main
2011-03-07
2011-01-20 61319
Type II
A) SSA-680A B) SSA-790A
ACTIVE Inhibin A ELISA
2011-03-07
2010-08-13 56202
Type III
10-28100, 10-28100-4
992721, 992809
QuickVue One-Step hCG Urine Test
Quidel Corporation
2011-03-07
2010-11-23 59757
Type III
20109
706842
CrossFt Suture Anchor with Two Hi-Fi Sutures Sireskop SX/SD Luminos
Linvatec Corporation D.B.A. Conmed Linvatec Siemens AG
2011-03-07 2011-03-07
2011-01-31 61296 2011-02-01 61361
Type II Type III
CFP-5502 10093754
211581 >10 Numbers, Contact Manufacturer
A) Spherasorb Carbon Dioxide Absorbent B) Loflosorb C) Intersorb Plus Continuous Flush Device 55UF130
Intersurgical Incorporated
2011-03-07
2011-01-28 61370
Type II
Edwards Lifesciences LLC
2011-03-07
2010-09-29 60283
Type III
A) 2196, 2197 B) 2198 C) 2194, 2195 55UF130
A) 1100392, 1101241, 1101426 B) 1101107, 1101427, 1101428 C) 1101240, 1101423, 1101902, 1102596 58495701, 58480446
Lite Wand Xe with Storz Cable
Thompson Surgical Instruments, Inc.
2011-03-07
2011-01-28 61311
Type III
40002X
N/A
HeartStart MRx Defibrillator/Monitor
2011-03-07
2011-02-07 61507
Type II
M3535A, M3536A
N/A
VCare Stan, Small, Large Cervical Cup
Conmed Corporation
2011-03-07
2011-02-15 61634
Type II
60-6085-100, 60-6085-101, 60-6085-102
090120X - 090731X
Tissue Retrieval System
Anchor Products Company Inc.
2011-03-07
2010-12-13 60291
Type II
TRS100SB, TRS175SB
P86N through Q24N
Multi M-Luminos TF
Siemens AG
2011-03-07
2011-02-02 61437
Type III
10093902
1070, 1071, 1072
Aria Radiation Oncology Updated recall # 57958 previously posted on 2010-11-08.
2011-03-07
2010-08-26 57958
Type II
Vision (Version 6.5)
H466050, H466051, H466052, H466053, H466057, H466058
Architect 25-OH Vitamin D - Reagent
Abbott GMBH & Co. K.G.
2011-03-21
2011-02-15 61697
Type III
3L52-25
01110L000
Optiflux F250NRe Dialyzers
Fresenius Medical Care North America
2011-03-21
2011-02-16 61779
Type II
0500325E
10HU02012, 10LU02016
Maxcem Elite Soft-Core Classic OptiBond FL Adhesive Refill LIFEPAK 20e Defibrillator UniCel DxC 800
Kerr Corporation Ormco Corporation, Also trading as Sybronendo Kerr Corporation Physio-Control, Inc. Beckman Coulter, Inc.
2011-03-21 2011-03-21 2011-03-21 2011-03-21 2011-03-21
2011-02-21 61829 2011-02-21 61830 2011-02-21 61848 2010-06-08 55155 2010-08-16 56203
Type III Type III Type I Type II Type III
34418 ESC-03006CL 25882 70402, 70507 4764
3360900 081006701 N/A >1000 Numbers, Contact Manufacturer A10407
A) InDura Intraspinal Catheter B) InDura 1P One-Piece Intrathecal Catheter C) InDura Closed-Tip Intrathecal Catheter D) Catheter Revision Kit -Distal
Medtronic Inc.
2011-03-21
2010-09-03 56454
Type II
A) 8703W B) 8709, 8709SC C) 8711, 8731, 8731SC D) 8598, 8598A
A) >10 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) >100 Numbers, Contact Manufacturer D) >100 Numbers, Contact Manufacturer
Cephalad migrations of catheter fragments, which may remain in intrathecal space either as a result of a catheter break, catheter shear or a physician's intentional decision not to remove unused catheter. / Migrations de fragments de cathter vers la tte, lesquels pourraient se loger dans lespace intrathcal, la suite du bris ou du cisaillement dun cathter ou de la dcision dun mdecin de ne pas retirer un cathter qui nest pas utilis. Model 5388 Dual-Chamber External Temporary Pulse Generators may be unable to power up or may power down unexpectedly. Beckman Coulter has confirmed customer reports of reagent pack to pack variability for the access thyroglobulin antibody II (TGAB) reagent. Issue 1: As of January 1, 2011, some fields are transmitted to the LIS empty fields if the year is greater than 2010. Issue 2: If the 1G1 transmission format is used, specific fields from the retic parameter group will not be transmitted. Stryker Orthopedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide causing the peg drill to cease functioning. Reason for the recall: INSTI Kits that contain blotted membrane units from lot number B1A128 may produce false positive results with the INSTI negative control or with a patient's sample. Three lots of INSTI were manufactured with the affected membrane units from lot B1A28: B1A135, B1A136, B1A137. DeRoyal is recalling the products after receiving a recall notice from the fabricator TriadGroup. That recall is due to concern by the US FDA over validation of the gamma radiation sterilization cycles.
External Pulse Generators Access System - Thyroglobulin Antibody II A) Gen-S Analyzer B) Coulter LH 780 Hematology Analyzer C) Coulter LH 750 Hematology Analyzer D) Coulter LH 500 Hematology Analyzer Stryker Triathlon PKR Peg Drills INSTI 24 Test Kit with out Support Materials
Medtronic Inc. Beckman Coulter, Inc. Beckman Coulter, Inc.
2011-03-21 2011-03-21 2011-03-21
2010-10-15 59975 2011-01-26 61292 2011-01-30 61367
Type II Type II Type II
5388 A32898 A) 6605381 B) 723585 C) 6605632 D) 178833, 178834 5650-4-512, 5650-4-536 90-1007, 90-1008, 90-1009
>10 Numbers, Contact Manufacturer 012741, 014751, 016551, 016838 A) All Lots B) All Lots C) All Lots D) All Lots All Lots B1A136, B1A135, B1A137
Howmedica Osteonics Corporation Biolytcal Laboratories Inc.
2011-03-21 2011-03-21
2011-02-09 61673 2011-02-11 62013
Type II Type I
Water Soluable Lubricant
DeRoyal Industries Inc.
2011-03-21
2011-01-21 61857
Type II
31-702, 31-704, 31-938
Level 1 Normothermic IV Fluid Admin Set
2011-03-21
2011-02-24 61931
Type I
DI-65HL, DI-75
1839591, 1839594, 1843949, 1870656, 1870658, 1873608, 1880864 become aware of an increased trend in reports of kinking of the tubing Smiths Medical has on certain sets. In some cases, the kink may lead to a decrease in the flow of fluid to the patient. A reduction in flow rate may lead to a delay of therapy, which could result in patient injury or death. / La socit Smiths Medical a observ une tendance croissante parmi les rapports sur les problmes de tortillement ou denroulement des tubes de certains lments. Dans certains cas, ces conditions peuvent entraner une rduction de lcoulement de fluide administr au patient. La rduction du dbit peut retarder lexcution adquate de la thrapie et causer des blessures au patient, voire entraner sa mort. 10-8344, UPC 5073083440 This recall has been initiated due to concerns expressed by The Food and Drug Administration regarding the validation of gamma radiation sterilization cycles. The recall was initiated because use of inadequately sterilized product might result in patient infection. / Le prsent rappel a t amorc la suite des proccupations de la Food and Drug Administration au sujet de la validation des cycles de strilisation par rayonnement gamma, car lutilisation de tout produit dont la strilisation est inadquate peut entraner linfection de patients. Bunnell Incorporated has initiated a voluntary recall to upgrade the Life Pulse Software from VP07 to VP08 in models 203 and 203a. The software upgrade addresses two primary issues and a number of minor items recently identified by an independent software validation analysis. / La socit Bunnell Incorporated a amorc un rappel volontaire afin deffectuer une mise niveau du logiciel de lappareil Life Pulse (modles 203 et 203a) et de passer de la version VP07 la version VP08. La mise niveau de logiciel vise rsoudre deux problmes principaux et un certain nombre de problmes mineurs qui ont t rcemment identifis dans le cadre dune analyse indpendante portant sur la validation du logiciel. Specific Lucas 2 devices have been experiencing failing probes in the hood, causing the device to malfunction and the led will start to flicker. / Des dispositifs particuliers de marque et de modle Lucas 2 ont prsent des problmes de dfaillance des sondes dans llment du type couvercle, ce qui entrane le fonctionnement dfectueux du dispositif et un clignotement des DEL de lafficheur. The Galileo Echo Blood Bank Analyzer may capture an invalid blank image of a test well and in remote instances, the system may generate a false test interpretation with no error or warning message generated. Beckman Coulter Inc. has identified four issues with the Unicel DXH 800 Coulter Cellular Analysis System: 1. Specimen tubes may fall out of a type A cassette when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts A cassette. 2. The DXH 800 may fail to meet the carryover specification for the WBC differential (DIFF) when the WBC is greater than 70 x 103 cells/ul (70 x 109 cells/l). 3. The DXH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 x 103 cells/ul (50 x 109 cells/l). 4. The handheld barcode scanner does not read barcode labels using NW 7 symbology. Beckman Coulter Inc. identified a problem with the barcode labels for the Lin-X (lot numbers 2681530k, 2661580k). The Unicel DXHT 800 Coulter Cellular Analysis System generated the error message 'XML parsing error' when attempting to read the label for any Lin-X level prior to analysis. An additional character that was included in the label caused the error. Components used in the production of Trudell's Nebulizer Kits have been identified as recalled product manufactured by Unomedical, Inc. The issue with the recalled oxygen masks is that there could be a sticky substance on the inside and/or outside of the mask that may manifest itself in approximately 6 to 8 months after manufacture of the product. The sticky masks could result in inconvenience and in some cases there is a remote possibility of potential harm to the patient. Preventive improvement of tube arm movement together with Bucky Table in order to reduce risk. DePuy Mitek is initiating a recall of specific lots of Gryphon BR Suture Anchors because of the potential presence of small metal debris in the shaft component of the device, which may have accumulated during the manufacturing process. Potential for out of specification osmolality and pH. Grit blast media was observed in the drive hole for lots containing Accolade TMZF Hip Stem.
Sterile Lubricating Jelly
Triad Disposables Inc.
2011-03-21
2011-01-05 60513
Type II
10-8344, 10-8472, 10-8500, 10-8917, 10-8919, IM-8919
Life Pulse High Frequency Ventilator Model 203 and 203A
Bunnell Inc.
2011-03-21
2011-01-26 61783
Type II
203, 203A
Lucas 2 - Chest Compressor
Jolife AB
2011-03-21
2011-02-16 61861
Type III
150000-01
Galileo Echo Blood Bank Analyzer
Immucor Inc.
2011-03-21
2011-02-15 61915
Type I
0087000
N/A
Unicel DXH 800 Coulter Cellular Analysis System
2011-03-21
2011-02-07 61686
Type II
629029
All Lots
Lin-X Linearity Control
2011-03-21
2011-02-14 61777
Type III
628029
2681530K, 2661580K
A) Disposable Nebulizer Kit-Pediactric B) Disposable Nebulizer Kit
Trudell Medical Marketing Limited
2011-03-21
2011-02-18 61943
Type II
A) M0293777E B) M0293776E
A) 1000800, 0900742 B) 1000783, 1000860
Mammomat Inspiration Gryphon P BR Anchor with Orthocord
Siemens AG DePuy Mitek
2011-03-21 2011-03-21
2011-02-08 61945 2011-02-25 61991
Type III Type II
10140000 210814
>10 Numbers, Contact Manufacturer 3463735
SoftPerm Contact Lenses A) Accolade TMZF Hip Stem - 132 (degrees) B) Accolade TMZF Hip Stem - 127 (degrees)
CIBA Vision Corporation Howmedica Osteonics Corporation
2011-03-21 2011-03-21
2011-02-18 61826 2011-02-22 61940
Type II Type II
SoftPerm A) 6020-0537, 6020-3535 B) 6021-0435
>100 Numbers, Contact Manufacturer A) 31390203, 31446602R B) 31597206
A) Accu-Chek FlexLink Plus Infusion Set B) Accu-Chek FlexLink Plus
Roche Diabetes Care AG
2011-03-21
2011-02-21 61990
Type II
A) 05511038001, 05511046001, 05511054001 B) 05510945001, 05510953001, 05511020001
A) GWX 001 - GWX 206, GWY 001 - GWY 033 B) GWX 001 - GWX 206, GWY 001 - GWY 033
When inserting the Accu-Chek FlexLink Plus Infusion Set there is a potential for under delivery due to a kinked/bent cannula. The impaired cannula may lead to reduced functionality of the infusion set and potential under delivery of insulin. If this remains unnoticed, it can result in elevation of blood glucose levels. Testing has revealed a stability issue that affects on-board assay performance over time. Based upon testing, we have revised the instructions for the Acticlot dPT test to reflect an "on-board" rehydrated stability of the dPT activator reagent of 8 hours at room temperature. Plastic enclosure on external power supply for Trusat Pulse Ooximeter may break, exposing the electrical board & line voltage, which could result in burn or electrical shock to user or caregiver. Difficulty in insertion of anatomic insert PE (polyethylene) to cementless baseplate during surgery. Hospira has received customer reports of the Plum A+ Infusion Pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues. Due to a problem with the fem luer component of this device, air may be entrained into the cardioplegia table line when negative pressure is applied to the circuit (during priming or aortic root venting). Due to a problem with the fem luer component of this device, air may be entrained into the cardioplegia table line when negative pressure is applied to the circuit (during priming or aortic root venting). A version of software associated with the CyberWand may cause sub-optimal performance such that the device fragments stones at a slower rate than is normally expected. A small percentage of devices may become damaged in transit causing the needle to become bent and/or the needle sheath to become dislodged. Echocardiography volume measurements that were performed within Cardiovascular Review Station (CRS) were not reflected correctly in associated results management (RM) reports. This occurred when echocardiography volume measurement data was not saved correctly within the CRS persistence data and in the RM database. The issue was caused when point-trace mode was enabled in CRS, a feature that was introduced in CRS 2.12.05. A software upgrade to CRS 2.14.03.SU2 will be made. Unexpected change in the configuration settings of the Accu-Chek Inform II and Accu-Chek Inform II RF Meters caused by a loss of flash memory in the database of the meter. There is a potential for erroneously high platelet (PLT), RBC, MPV, and hematocrit (HCT), results to be generated. The erroneous results may occur on the first aspiration of a tube and may occur without instrument generated messages. Testing has demonstrated an average probability of occurrence of erroneous elevated platelet counts on the first aspiration of a specimen tube of 0.6% with a 95% confidence interval of 0.21% to 0.99%. The control recovery for Von Willebrand Reagent lot 506510 control plasma N and control plasma P has been found out of range due to a performance issue of the affected lot. Therefore, patient results cannot be released. The precision flow is sounding an alarm and will not operate when some disposable patient circuits are first inserted into the main unit. The affected trays contain alcohol prep pads that are included in the scope of a field correction initiated by triad group, who supplies the alcohol prep pads. This field correction was initiated by triad group due to concerns about potential bacterial contamination of the prep pads. If contaminated alcohol prep pads are used, there is a potential for infection to occur. With some specific plan types, the treatment planning system can over predict dose to targets resulting in potential under dose. The plan elements necessary to encounter this issue are sharp dose gradients with few, simple and small axial cross section targets located off central axis. Steris Corporation has learned that the Harmony LA / LED Monitor Arm Adapters may become unstable when used in conjunction with lead shields or comparable medical devices that exceed the weight and moment limitations of monitor arm adapter. The weight and orientation of these devices may result in suspension system instability and damage to the monitor arm adapters. Edwards Lifesciences has discovered that the subject devices were shipped into Canada in error without Health Canada compliance status under the licensing, investigational testing, or special access provisions of the medical devices regulations. In addition, some lots of the devices included instructions for use applicable to a 3 cm balloon device, not the 4 cm balloon configuration of the subject devices. One lot of the vented needle (305213) was incorrectly labelled at the unit package level with the non vented needle (305216) top web at the web at the unit packaging level. Case carton and shelf carton were labelled properly with vented needle (305213) information. This update instruction should help to recognize faulty gradient cable connections and subsequently prevent those from overheating. Thermal sensors (self-adhesive labels) will be attached to the connections identified as critical.
Acticlot dPT
American Diagnostica Inc.
2011-03-21
2011-03-03 61637
Type II
824
101028
A) Trusat Oximeter B) Trusat Oximeter - with Expension Option A) T.E.S.S. - Insert Glenoidien B) T.E.S.S. Embase Glenoidienne - without cement A) Plum A+ Volumetric Infusion Pump B) Plum A+3 Infusion Pumps Sarn's Cardioplegia Sets
GE Healthcare Finland OY
2011-03-21
2011-03-01 61678
Type I
A) 6051-0000-190, 6051-0000-192 B) 6051-0000-191, 6051-0000-193 A) P1700120, P1700178, P1700180 B) P1700110, P1700122, P1700124 A) 12391, 20679, 20792 B) 12618, 20678 16130
A) >10 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer A) All B) All A) All B) All Lots Lots Serial Numbers Serial Numbers
Biomet France Sarl Hospira Inc.
2011-03-21 2011-03-21
2010-12-16 61742 2011-02-15 61913
Type II Type I
Terumo Cardiovascular System Corporation
2011-03-21
2011-03-01 62094
Type II
ME12, MK02
A) Cardiovascular Procedure Kit (conducer no recirc.double spike) B) Cardiovascular Procedure Kit (Cabaret de Perfusion) CyberWand Dual Ultrasonic Lithotripsy System
Terumo Cardiovascular System Corporation
2011-03-21
2011-03-01 62095
Type II
A) 71032 B) 73007
A) ME19, ME19R, MG21, MK09, MN01 B) MM11
Gyrus ACMI, Inc.
2011-03-21
2011-03-02 62108
Type III
CW-USLG, CW-USLS
GAXXXXXXX0001 to GAXXXXXXX0226
A) Orbit 90 Subcutaneous Infusion Set B) Orbit Micro Subcutaneous Infusion Set Cardiovascular Review Station
ICU Medical, Inc.
2011-03-21
2011-01-28 59838
Type II
AGFA HealthCare N.V.
2011-03-21
2011-01-27 61451
Type II
A) M1861, M2461, M2491, M3091, M4261, M4291, P1861, P1891, P2461, P2491, A) >10 Numbers, Contact Manufacturer P3061, P3091, P4261, P4291 B) >10 Numbers, Contact Manufacturer B) P1851, P2451, P3051, P4251 60+00007792 N/A
A) Accu-Chek Inform II Meter B) Accu-Chek Inform II + RF Meter AcT 5diff Series Hematology Analyzer
2011-03-21
2011-02-15 61885
Type II
A) 05060311001 B) 05060303001 175356
2011-03-21
2011-02-21 61994
Type II
A) UU11038344, UU11006762, UU11006763, UU11006766, UU12005334 B) >100 Numbers, Contact Manufacturer All Lots
von Willebrand reagent
2011-03-21
2011-02-08 62032
Type III
OUBD23
506510
Precision Flow Disposable Patient Circuit - Low Urethral Procedural Tray with Syringe
Vapotherm, Inc. Teleflex Medical
2011-03-21 2011-03-21
2011-02-18 62122 2011-03-03 62126
Type III Type II
PF-DPC-LOW 67890, 68895
LF1101012 >10 Numbers, Contact Manufacturer
Tomotherapy Treatment System - Main Unit
Tomotherapy Incorporated
2011-04-04
2011-01-11 61948
Type II
H-0000-0003
Harmony LA / LED Monitor Arm Adapter
Steris Corporation
2011-04-04
2011-02-28 62027
Type III
LB61
05004909100005
Edwards Balloon Catheter
2011-04-04
2011-03-02 62082
Type II
9350BC20, 9350BC23
All Lots
BD Nokor Vented Needle
Becton Dickinson
2011-04-04
2011-03-02 62125
Type III
305213
0007829
A) Magnetom Espree B) Magnetom Trio A Tim System C) Magnetom Trio A Tim System-Upgrade D) Magnetom Avanto, System Precinorm PUC Stem-Trol Control Cells NAC MLL Needles
Siemens AG
2011-04-04
2011-02-28 62127
Type III
A) 10018165 B) 10018221 C) 10018222 D) 7391167 03121313122 N/A NAC 1410MLL, NAC 1825MLL
Roche Diagnostics GMBH Beckman Coulter, Inc. Remington Medical, Inc.
2011-04-04 2011-04-04 2011-04-04
2011-02-16 61881 2011-02-28 62031 2011-02-18 62139
Type III Type III Type III
A) >10 Numbers, Contact Manufacturer B) 35109, 35120, 35130, 35368, 35382, 35421, 35434, 35442 C) 35049, 35056 D) >10 Numbers, Contact Manufacturer 157086 24,25,26,27 083384 (NAC1410MLL), 083383 (NAC1825MLL), 090582 (NAC1825MLL) 1091745
Labelling error since the wrong version of the value sheet was provided for the product Precinorm PUC lot # 157086. Wrong expiration date of 2010 July 26 instead of 2010 June 26. Potential for the needle hubs to break during use.
Medi-Vac Specimen Sock
Cardinal Health
2011-04-04
2011-03-07 62156
Type II
65652-123, 65652-124
Pronto 7 (PDC SC) Reusable Sensor
Masimo Corporation
2011-04-04
2011-01-28 62189
Type II
2920, 2951, 2952, 2953, 2954, 9147
All serial numbers from A83F90 and up.
The recall has been initiated due to a labelling issue. Cardinal Health has received one report of customer receiving 65652-124 in a packaged labelled as 65652-123 with lot number 1091745 manufactured 11/16/2009. When performing an SpHb measurement in cold conditions, the Pronto-7 Rainbow Reusable Sensor may incorrectly measure actual finger temperature. As a result, Pronto-7 spot check pulse co-oximeter may provide an incorrect SpHb measurement.
A) Synchromed EL B) Synchromed II - Programmable Pump Precipost DT
Medtronic Inc. Hospira Inc.
2011-04-04 2011-04-04
2011-01-16 61855 2011-02-15 61913
Type I Type I
A) 8626-10, 8626-18, 8626L10, 8627-10, 8627-18, 8627L10, 8627L18 B) 8637 11005
A) >100 Numbers, Contact Manufacturer B) >1000 Numbers, Contact Manufacturer All Serial numbers
A) Orthoralix DDE Panoramic Dental X-Ray System B) Orthoralizx 9200 DDE Panoramic Dental X-Ray System C) Orthoralix 9200 DDE Plus CEPH COBAS AmpliPrep Sample Rack Masimo Set Rad-8 Pulse Oximeter
Imaging Sciences International, LLC DBA Gendex Dental Systems Roche Diagnostics Ltd. Masimo Corporation
2011-04-04
2011-02-17 62137
Type III
2011-04-04 2011-04-04
2011-02-16 61882 2010-12-22 62190
Type III Type II
A) 110-0199G2, 110-0199G4, 110-0234G3 B) 51050161WW, 51050181WW C) P9200DDE, P9200DDEC, P9212DDE 03051315001, 05078903001, 28122172001 1844, 1959, 1961, 1963, 9192, 22595, 9019, 9049, 9073, 9193, 9165, 9174, 9190, 9194, 9212, 1845, 1960, 1962, 9195, 9224, 1964, 9020, 9050, 9074, 9166, 9175, 9191, 9213
A) N/A B) N/A C) N/A 2009/10, 2010/02, 2010/06 Versions earlier than V1.3.1.0
Potential for a pocket fill during a Synchromed II or Synchromed EL implantable drug pump refill procedure. Hospira has received customer reports of the Plum A+ Infusion Pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues. There is an anomaly in the firmware which can cause message corruption during periods of high network traffic that can distort the digital image being transferred from the x-ray system to the PC. COBAS AmpliPrep Sample Racks are out of specification and may cause aborted runs. Rad-8 devices have been noted to revert back to factory default settings after power cycle despite the user having configured the device with custom settings previously.
Haemophilus ID Quad GEM Premier 4000 Analyzer
Remel Inc. Instrumentation Laboratory Company
2011-04-04 2011-04-04
2011-02-25 61992 2011-02-24 62121
Type II Type II
RE02460 00025000000
982564 06050100 to 11024479
Incorrect expiry date printed on outside box (February 19, 2011) it should have been January 19, 2011. In rare instances, a measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results with potentially severe impacts to patient treatment. On January 11 2011, Baxter Corporation notified customers that Energizer C-size alkaline batteries should not be used with the INFUSO.R. Pump (recall number 60650). The purpose of this new communication is to inform customers that: a second device, the Mini-Infuser system, uses the same size battery and incorporates the same battery contact interface, and, that other brands of C-size alkaline batteries may incorporate the same feature that inhibits electrical contact. During the initiation of a global recall for specific lots of DePuy Cement Restrictors regarding a packaging issue (recall number 61458), Johnson & Johnson Medical Products identified that, due to an administrative error, the necessary medical device licence applications had not been filed with Health Canada to sell these devices. During the initiation of a global recall for specific lots of DePuy Cement Restrictors regarding a packaging issue (recall number 61458), Johnson & Johnson Medical Products identified that, due to an administrative error, the necessary medical device licence applications had not been filed with Health Canada to sell these devices. Smoke emerging from certain models of Maxi Sky 1000 ceiling lift cassettes (motor). Smoke emerging from certain models of V10 Bariatric ceiling lift cassettes (motor). If another patient is selected on the imaging system (XVI release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI information is prioritized and the end of treatment data is never received by the R&V system. This leads to a potentially misleading dialogue on the R&V system that may result in a re-treat of field just completed. The contact manufacturer informed Diasorin Inc. of the potential for the premature failure of certain cooling modules. The affected cooling modules were assembled incorrectly and as a result heat generated by the Peltier (thermo-electric cooler) units of the cooling module may not be properly dissipated. The heat build up may shorten the expected lifespan of the cooling module. Failure of the cooling module could cause the temperature in the liaison analyzer reagent area to exceed allowable limits. Some units of device contain back links that may compromise knee function prematurely. Heavy use of prosthetic may result in patient injuries, due to possible failure of device. DRB3*01 and DRB5*02 alleles are not listed on the hit tables for both the manual interpretation analysis method and the method using PMP (pattern matching program) software. The user will not be able to get any typing results for the DRB Kit. In addition, no HLA typing results will be given for DRB3*01 and DRB5*02 alleles. Internal process discrepancies have been identified with regard to the RELI SSO products. The listed products, used for HLA typing, were released to the market with aged oligos (probes and primers) used in manufacturing without sufficient stability data to support this practice. For previously assigned HLA typings using the affected kits, customers must review and confirm the results using an alternate method. This recall has been initiated due to product below specified hardness. The tubes are too pliable and would be difficult to use for intubations. There is a possibility that the tube could fold over in the narrower areas of assembly. Supplier of LTS-D products noted in their process and informed King Systems on January 21, 2011. Occurrence of septum missing on some bottles of Pre Clean M for lot # 63330401.
A) INFUSO.R. Pump B) Mini Infuser System
2011-04-04
2011-03-04 62229
Type III
A) 2L3100, 6461500 B) 2M8171, 6465300, 6465300R
A) DePuy Cement Restrictor B) DePuy Cement Restrictor (Universal)
DePuy Orthopaedics, Inc.
2011-04-04
2011-03-08 62231
Type III
A) 5460-10-000, 5460-12-000, 5460-14-000, 5460-16-000, 5460-18-000, 5460-20000, 5460-22-000 B) 5461-01-000, 5461-10-000, 5461-12-000 N/A
Hardinge Femoral Cement Restrictor
DePuy International Ltd.
2011-04-04
2011-03-08 62237
Type III
Maxi Sky 1000 BHM Medical V10 Elekta Synergy XVI R4.5 - MRT13221
ArjoHuntleigh Canada Inc. BHM Medical Inc. Elekta Limited
2011-04-04 2011-04-04 2011-04-04
2011-02-22 61972 2011-02-22 62262 2011-02-07 61735
LF20010, LF20011, LF20013, LF20014, LF20015, LF20019 9120001, 9120004, 9120005, 9120008, 9120009 MRT 13221
Lots from Jan. 2005 to Jan. 2011 Lots from Jan. 2005 to Jan. 2011 152164, 152159, 152160, 105871, 151940
A) Liaison Analyzer - Instrument Class III B) Liaison Analyzer - Instrument Class II
Diasorin Inc.
2011-04-04
2011-02-16 61842
Type III
A) 15970 B) 15970
A) N/A B) N/A
Total Knee 2100 HLA-DRB Typing Kit 50 Test
Ossur Americas Inc. Invitrogen Ltd.
2011-04-04 2011-04-04
2011-02-14 61927 2011-03-16 62287
Type II Type III
N/A 810-45
Contact Manufacturer 8801576H
A) HLA-A Typing Kit, Including Mastermix B) HLA-B Typing Kit C) HLA-CW Typing Kit D) HLA-DRB Typing Kit, Including Mastermix E) HLA-DQB1 Typing Kit, Including Mastermix King Systems LTS-D Airway
Invitrogen Ltd.
2011-04-04
2011-03-16 62288
Type III
A) 830.01, 83022 B) 840.01 C) 850.01 D) 810-45, 81022, 86022 E) 820.01, 82022 KLTSD405
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer 201011-169
King Systems, A Consort Medical Company
2011-04-04
2011-01-24 61402
Type II
Pre Clean M
2011-04-04
2011-02-16 62096
Type III
03004899190
63330401
Cobas Integra Calcium
2011-04-04
2011-03-03 62097
Type II
20763128322
630204-01
Imprecision and erroneous patient results observed with the calcium on Cobas Integra and to a lesser extend on Cobas C501 systems using the reagent lot #630204-01. Accuracy of the displayed parameters revealed that users may not be aware that the displayed values could be drifting or inaccurate. Immediately after creating a setup field in RT chart version 7.3.10, the focus reverts to the treatment field. Varian has received reports that users have sometimes failed to notice this focus, and have proceeded to delete MLC and other accessory components from the field, in the mistaken belief they were acting on the setup field. There is a potential for either the head section or the foot section of the bed to drop unexpectedly, if preventive maintenance of the screw box has not been conducted. False alarms conditions where the user reported being able to reset the alarm and other times not being able to reset the alarm to allow further air bubble detection. The link arm assembly that connects some rear mounted options (cuspidors, assistants instrumentation, and hygiene systems) to the Spirit 3000 Dental Chair may break and fall of the dental chair.
A) CDI System 100 B) CDI 101 Aria Software
Terumo Cardiovascular Systems Corporation Varian Medical Systems, Inc.
2011-04-04 2011-04-04
2010-10-11 61636 2011-02-07 62335
Type II Type II
A) 100 B) 101 Vision (Version 6.5)
A) 100-001 to 100-1687 B) 1070 to 1697 H831103, H833652
Medical Bed Model FLH668DCM Sarns Ultrasonic Air Sensor Cable Spirit 3000 Dental Chair
Stryker Medical Terumo Cardiovascular Systems Corp. Pelton and Crane
2011-04-04 2011-04-18 2011-04-18
2011-03-09 62361 2011-03-10 58270 2011-03-03 62140
Type II Type II Type III
FLH668DCM 149892, 78-8067-7375-6 3003, 3004
All Serial numbers 29396 16964, 16934
A) HMX Hematology Analyzer B) Coulter LH 500 Hematology Analyzer A) External Nasal Splint Kits B) Thermasplint Kits Electric Bed Model FLH668NDCM
2011-04-18
2011-02-28 62152
Type II
A) 6605523, 6605526 B) 178833 A) 1528116, 1528126, 1528136 B) 1529100, 1529110, 1529120 FLH668NDCM
Medtronic Xomed Inc. Stryker Medical
2011-04-18 2011-04-18
2011-02-24 62165 2011-03-09 62221
Type II Type II
A) 6605522, 6605523, 6605524, 6605525, 6605526, 6605527 B) 178832, 178833, 178834 A) All lots since January 2008 B) All lots since January 2008 All lots
Beckman Coulter has identified an issue with suspect counterfeit integrated circuit (ICS) chips have been found in LH500 and HMX units at installations and in instrument manufacturing. The alcohol prep pads contained in the kits may be contaminated with bacillus cereus. Stryker Medical has become aware that the medical bed model [originally manufactured by Bertec Medical] has the potential for either the head section or the foot section of the bed to drop unexpectedly, if preventive maintenance has not been conducted, as specified in the owner's manual.
Cobas 4800 - Cobas X480 Module
Roche Molecular Systems, Inc.
2011-04-18
2011-03-10 62268
Type II
05200890001
55152192, 55151324, 55154131, 55152629
A) Prick Lancetter B) Quintest Skin Test Device C) Quintip Individual Skin Test Device D) Small Pox Needle
Hollister-Stier Laboratories LLC
2011-04-18
2011-03-15 62327
Type II
A) N/A B) N/A C) N/A D) N/A
Occurrence of misadjustment of the iswap (automated plate handler) component of the Cobas 4800/Cobas X480 sample preparation module. This situation could be linked to a possible cross contamination during sample preparation. A) >10 Invoice Numbers, Contact Manufacturer t Inspection of Canadian importer Omega Laboratories Ltd indicated this unlicensed product B) Invoice / Facture # 575174 was being imported for sale. C) Invoice / Facture # 561327, 569864, 622540, 639811, 641983, 641984, 678141, 729967 D) >10 Invoice Numbers, Contact Manufacturert
A) Argon Arterial Catheter Kit B) PCI Kit with Feathered Dilator, Pediactric Reflection 3 Acetabular System - INTL Ceramic Acetabular Liners
Argon Medical Devices Inc.
2011-04-18
2011-03-14 62404
Type II
A) 498100, 498104, 498106, 498447 B) 496310, 496311 71331648, 71331652
A) 99768223, 99768103, 99767388, 99767634 B) 99768100, 99767643 10FT43676, 09JT35943, 10FT43611
Smith & Nephew, Inc.
2011-04-18
2011-03-14 62299
Type II
A) Axiom Aristos FX Plus B) Axiom Aristos FX
Siemens AG
2011-04-18
2011-02-16 62435
Type III
A) 10093864 B) 7414803
A) 1042, 1189, 1191, 1192 B) >10 Numbers, Contact Manufacturer
A) Accu-Chek FlexLink Plus Infusion Set B) Accu-Chek FlexLink Plus Updated recall # 61990 previously posted on 2011-03-21.
Roche Diabetes Care AG
2011-04-18
2011-02-21 61990
Type II
A) 05511038001, 05511046001, 05511054001 B) 05510937001, 05510945001, 05510953001, 05510961001, 05510970001, 05510988001, 05510996001, 05511003001, 05511020001, 05511089001
A) GWX 001 - GWX 206, GWY 001 - GWY 033 B) GWX 001 - GWX 206, GWY 001 - GWY 033
A number of multi-purpose kit blister trays were found with a hole in them. The defect could impact the sterility of the product which could potentially cause infection or an adverse reaction. During the manufacturing phase for certain batches of the R3 ceramic acetabular liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by the manufacturing specifications. This has the potential to result in lower than expected strength for the liners. The update instruction will inform customers about potential danger of Aristos FX and Aristos FX Plus Systems having an older version of the detector alpha rotation assembly, where the screws of the clutch assembly may break causing a hinge down of the detector unit. When inserting the Accu-Chek FlexLink Plus Infusion Set there is a potential for under delivery due to a kinked/bent cannula. The impaired cannula may lead to reduced functionality of the infusion set and potential under delivery of insulin. If this remains unnoticed, it can result in elevation of blood glucose levels.
Rapid Response HUT Table Hitachi/Cobas Integra Preciset sTfR Millar Disposable Angiographic Catheter (Left Heart) SureStep Flexx Blood Glucose Bedside Unit
Medical Positioning, Inc. Roche Diagnostics GMBH Millar Instruments Inc. LifeScan Inc.
2011-04-18 2011-04-18 2011-04-18 2011-04-18
2010-05-05 62293 2011-03-11 62426 2011-03-09 62430 2011-03-06 62469
Type II Type III Type I Type III
1017, 1117, 1217 12148331122 SPC-454D 020-185, 022-328
598972 to 600809 63793501, 64243701 >10 Numbers, Contact Manufacturer N/A
The head-up tilt function may intermittently fail. Occurrence of non mono flags on the Cobas Integra platform when calibrating the tinaquant soluble transferrin receptor assay. Potential that the catheter contains small particles of epoxy debris within the catheter lumen. Some SureStep Flexx Blood Glucose Bedside units (hospital meters) may not download data from the meter, when the meter is placed in the cradle with connection module, to the central repository (work station) at the hospital. This does not impact any other meter functionality. Certain lots were labelled sterile, but were not. Three lots of this power supply were built with a single layer of insulation used in the transformer, instead of the 3 layers minimum per product specification. Safety regulations require a minimum of 2 layers of insulation in the transformer. These devices may not meet required medical device electrical safety standards and may result in an increased potential for electric shock. The fan assembly of the power supply for certain system 98/98XT, CS100/CS100I and CS300 IABPS could potentially contain a misshapen retaining ring. This retaining ring could disengage within the fan, causing the fan blade assembly to stop rotating. Consequently, the power supply would detect an overheating event, and shut down without visual or audible alarms. Hospira has received complaints for the Plum XL Infusion Pumps related to no audible alarm conditions. Users reported that during an alarm condition, the pump displays a visual alarm, but the alarm buzzer does not audibly sound.
Curvtek Eye Needles Padgett Model S Slimline Electric Dermatome Kit
Biomet Sports Medicine Integra Lifesciences Corporation
2011-04-18 2011-04-18
2011-03-10 62301 2011-03-16 62344
Type II Type II
906764 3539-700
748730 S-386, S-723, S-907
A) CS300 Intra Aortic Balloon Pump System B) CS100 Intra Aortic Balloon Pump
Datascope Corporation
2011-04-18
2011-03-23 62466
Type II
A) 0998-00-3023-XX B) 0998-00-3013-XX
A) S807282-E3, SL15602-1C9, SL135791GB B) SA04837-L5, SA01419-A4
A) Plum XL B) Plum XL Micro/Macro Infusion System C) Plum XL 3 Multi-Line Infusion System D) Plum XL 3 Micro/Macro Infusion System E) Plum XL Micro/Macro Infusion / Data Port Selenite Broth NX Modality Workstation
Hospira Inc.
2011-04-18
2011-02-14 62511
Type II
bioMrieux, Inc. Portland Agfa HealthCare N.V.
2011-04-18 2011-04-18
2011-01-21 60979 2011-03-07 62157
Type III Type II
A) 11555 B) 11846 C) 11781 D) 11845 E) 11859 T3560, T7340 N/A
A) >100 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >100 Numbers, Contact Manufacturer E) >100 Numbers, Contact Manufacturer >10 Numbers, Contact Manufacturer Software Versions 2.0 .8100, 3.0 .8100, 2.0 .8200, 3.0 .8200, 2.0 .8300, 3.0 .8300, 2.0 .8400, 3.0 .8400, 2.0 .8500, 3.0 .8500 HMO #196, HMO #197
Several lots of Selenite Broth were manufactured using selenite cystine broth instead of the intended raw material, selenite. An image can be presented with the wrong patient name displayed above it. This can cause confusion for the user and possibly result in the incorrect application of image markers or annotations. MA control test is out of range (low).
TEG Hemostatis Analyzer-Controls
Haemonetics Corporation D.B.A. Haemoscope Corporation Zevex Inc. Also trading as: Moog Medical Devices Group
2011-04-18
2011-03-04 62267
Type II
8002
A) PainSmart IOD (Ambulatory Infusion Pump) B) 6000 CMS (Ambulatory Infusion Pump)
2011-04-18
2011-03-07 62274
Type I
A) 360-1200, 360-1300, 360-1300P B) 360-1100, 360-1400
There is the potential for a possible delay in therapy that may result during the use of software version 6R9, 6R9A, 6R9B, 6R9C, 6R9D and 6R9E. Pumps programmed with previously mentioned software revisions may display a false error code 45 (motor condition loss of sync). This software anomaly renders the device in-operable until a recovery process is performed. Recovery from error code 45 requires a power cycle of the pump during which the date, time and all customized therapeutic parameters are lost. The recovery process requires all such parameters to be re-inputted by the clinician prior to beginning or resuming therapy. There is a typographical error on one of the 4 peel-off stickers that are placed on the subject product packaging. The information on one of the stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length. The issue detected is that the package, which is properly labelled (11GX 6-inch), contains a 13GX 4-inch side-hole needle. As the needle contained within the affected package is two inches shorter in length, it could result in an inability to get the shorter needle to the desired location. A limited number of Teledyne R15 oxygen sensors were found to leak electrolyte gel.
Codman Enterprise Vascular Reconstruction Device
Codman & Shurtleff, Inc.
2011-04-18
2011-03-21 62527
Type III
ENF452812
1421338, 1421601, 1422396, 2420432
Confidence Introducer Needle, Diamond
DePuy Spine, Inc.
2011-04-18
2011-03-25 62528
Type II
2839-03-611
HLPB4G
Oxygen Sensor
Teledyne Instruments, Analytical Instruments
2011-04-18
2010-12-07 60029
Type II
R-15
617654, 617655, 617656
A) King LT-D Kit (Size 3, Size 4, Size 5) B) King LTS-D Kit (Size 3, Size 4, Size 5) C) King LT-D Kit (Size 2, Size 2.5)
King Systems, A Consort Medical Company
2011-04-18
2011-01-14 62044
Type II
A) KLTD213, KLTD214, KLTD215 B) KLTSD413, KLTSD414, KLTSD415 C) KLTD212, KLTD2125
A) ITI16, IUAL9, IRMS3, IU2U7, IU7M5, IU2U8, IU6V7, IUBN6 B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer A) >100 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer
King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use of this product may result in "patient infection". This particular sterile lubricating jelly is packaged in the King LT-D Kit and King LTS-D Kit, so King Systems is notifying our customers of the recall. 1) Cardiac output values may be calculated incorrectly if default catheter settings used. 2) ECG "leads off" alarm may not be activated with a specific user workflow, which could lead to complete loss of ECG monitoring.
A) Carescape Monitor B850 System - C1 CPU GE Medical Systems Information Technologies, Inc. B) Carescape Monitor B850 System - C1 CPU with Third Video
2011-04-18
2011-03-28 62542
Type I
A) 2020913-002 B) 2020913-003
A) InterLink System Secondary Medication Set B) Basic Solution Set C) Continu-Flo Solution Set D) Buretrol & Interlink System Buretrol Solution E) Transfer Set F) Secondary Med Set with 18G Needle Lock G) Extension Set H) MiniVolume Extension Set I) InterLink System Extension Set J) ClearLink System Extension Set K) ClearLink System Non-DEHP Micro-Volume Extension L) Mini-Infuser Microbore Extension Set M) Basic Solution Set with Duo-Vent Spike N) Solution Set with Duo-Vent Spike O) InterLink System Basic Solution Set P) InterLink System Solution Set Q) InterLink System Vented Basic Solution Set R) Interlink Basic Solution Set, Polyeth Lined S) InterLink Solution Set with Restrictive Tubing T) InterLink System Solution Set with Duo-Vent Spike U) InterLink Non-DEHP Solution Set with Duo-Vent V) ClearLink System Solution Set W) ClearLink System Slotion Set with Duo-Vent Spike X) InterLink System Continu-Flo Solution Set Y) ClearLink System Continu-Flo Solution Set Z) Nitroglycerin Set with Duo-Vent Spike
Baxter Corporation
2011-04-18
2011-03-15 62362
Type III
A) JC7451 B) JC5383, JC5387, JC5417, JC5418, JC5421, JC5423, JC5425, JC5439, JC5442, JC8109 C) JC0430, JC5380N, JC5386N, JC5537N, JC5546N D) JC5378, JC5379, JC7505, JC7534, JC7546, JC7560, JC7562, JC7564, JC7565, JC7568 E) CM0501, JC2251 F) JC7430, JC7431 G) JC1196, JC1197, JC1198, JC5620, JC5628, JC5630, JC5641 H) JC9944 I) JC6606, JC6612, JC6613 J) JC8612 K) JH8396 L) JC9201 M) JC5408 N) JC5419 O) JC6401, JC6403 P) JC6425 Q) JC6429 R) JC7563 S) JC6421 T) JC6419 U) JC7569 V) JC8401 W) JC8419, JC8428 X) JC6386, JC6502, JC6519, JC6520, JC6546 Y) JC8386, JC8519, JC8537, JC8546 Z) JC7551, JC7552 A) JC7453 B) JC7462 C) JC7791 D) JC2038, JC7781, JC7790 E) JC7627C F) JC7724 G) JC7751 H) JC6392, JC6714, JC6720, JC6723 I) JC8723 J) JC8750 IOSS413
A) ClearLink System Secondary Medication Set B) ClearLink Secondary Med Set with Duo-Vent C) Paediatric Straight Type Blood Set D) Straight Type Blood Set E) Y-Type Blood/Solution Set F) Y-Type Blood/Solution Set with Large Standard Filter G) Y-Type Blood/Solution Set with Standard Blood Filter H) InterLink System Y-Type Blood/Solution Set I) ClearLink Y-Type Blood/Solution with Large Standard J) ClearLink Y-Type Blood/Solution with Standard Blood Osseotite Certain Implant
Baxter Corporation
2011-04-18
2011-03-15 62362
Type III
Biomet 3I, Also Trading as Implant Innovations, Inc. Baxter Healthcare Corporation
2011-04-18
2011-03-11 62560
Type II
A) >100 Numbers, Contact Manufacturer B) >100 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >100 Numbers, Contact Manufacturer E) ST10E170, ST10I004 F) >10 Numbers, Contact Manufacturer G) >100 Numbers, Contact Manufacturer H) ST10E042, ST10I027, ST10I172, ST10J254 I) >10 Numbers, Contact Manufacturer J) >10 Numbers, Contact Manufacturer K) ST09A269, ST09B225, ST09B312, ST09C049, ST09C190, ST09K036, L) >10 Numbers, Contact Manufacturer M) ST10C099, ST10J060 N) ST10A405, ST10E004 O) >10 Numbers, Contact Manufacturer P) >10 Numbers, Contact Manufacturer Q) >10 Numbers, Contact Manufacturer R) ST10A158, ST10A325, ST10B256, ST10E100, ST10F214, ST10H092, ST10I072, ST10I157, ST10K017 S) ST09A189, ST09E156, ST10G168 T) >10 Numbers, Contact Manufacturer U) ST10B195, ST10J194 V) >10 Numbers, Contact Manufacturer W) >10 Numbers, Contact Manufacturer X) >100 Numbers, Contact Manufacturer Y) >100 Numbers, Contact Manufacturer Z) ST10B194, ST10E039, ST10I256 A) >100 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) ST10B047 D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer G) >100 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer J) >10 Numbers, Contact Manufacturer 2009110838
Baxter Corporation has received reports of package brittleness and packaging tearing easily. Investigation of these reports indicates that the issue may appear after 12 months and only on some lot numbers.
Baxter Corporation has received reports of package brittleness and packaging tearing easily. Investigation of these reports indicates that the issue may appear after 12 months and only on some lot numbers.
Some implants may have a condition affecting the internal thread. The condition will prevent the cover screw, temporary healing abutment, final restorative abutment, etc. from engaging the implant. Baxter is issuing a safety alert to dialysis center clinicians to make them aware of safeguards that should be considered with seizure prone patients and other at-risk patients unable to care for themselves due to transient or permanent impairments during HomeChoice peritoneal dialysis therapy. This follows a reported patient death linked to tubing entanglement around the neck. Baxter is issuing a safety alert to dialysis center clinicians to make them aware of safeguards that should be considered with seizure prone patients and other at-risk patients unable to care for themselves due to transient or permanent impairments during HomeChoice peritoneal dialysis therapy. This follows a reported patient death linked to tubing entanglement around the neck. The System 1 circuit breaker is located at the back of the base very close to the floor. Due to the location and design of the circuit breaker it can be inadvertently tripped by personnel or other equipment operating in the vicinity of the System 1 base through incidental contact. May produce false negative or weak positive reactions from the NPA test (nitrophenylalanine). Zimmer is initiating a recall of certain lots of NexGen Complete Knee Solution (CKS) posterior referencing instruments (PRI) because they have a potential for exhibiting a breakdown of the aluminum/titanium nitride PVD black coating. The NexGen PRI utilize this coating as a cosmetic means to depict points of attachment or adjustment of the instruments.
Automated Peritoneal Dialysis Sets
2011-04-18
2011-03-22 62529
Type II
5C4480C, R5C4479C, N5C8305C
All lots
Automated Peritoneal Dialysis Sets
Baxter Healthcare Corporation, Renal Division
2011-04-18
2011-03-22 62536
Type II
R5C4478, R5C4427
All lots
Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
2011-04-18
2011-02-23 62534
Type II
801763
0011-0610, 1001-1182
O.B.I.S. Salmonella A) NexGen CKS Quick-Connect Handle B) NexGn CKS Posterior Referencing Sizer C) NexGen CKS Postier Referencing Sizer Boom D) NexGen CKS Modular T-Handle E) NexGen CKS Distal Femoral Resection F) NexGen CKS Femoral Valgus Alignment G) NexGen CKS Extramedullary Distal Telescoping H) NexGen CKS Extramedullary Proximal Telescoping I) NexGen CKS Extramedullary Modular Spike J) NexGen CKS Patella Osteotomy Guide K) NexGen CKS Patella Clamp L) NexGen CKS Femoral & Provisional Impactor/Extractor M) NexGen CKS Patella Peg Drill Guide
Oxoid Limited Zimmer Inc.
2011-04-18 2011-04-18
2011-03-25 62535 2011-03-24 62538
Type II Type II
ID0570M A) 00590103400 B) 00590104000 C) 00590104010 D) 00590106100 E) 00590106300 F) 00590106700 G) 00590107100 H) 00590107200 I) 00590107400 J) 00590301000 K) 00590302000 L) 00590102600 M) 00590306000
N/A A) 61612789, 61682485, 61550601 B) 61558673, 61610687 C) 61558201 D) 61517185, 61609572 E) 61548704, 61615895 F) 61559529, 61625078 G) 61559187, 61633778 H) 61543636 I) 61549223, 61593951 J) 61559367 K) 61555948, 61635432 L) 61522231, 61550613, 61637191, 61657309, 61659596 M) 61511575, 61542246, 61630733
NexGen CKS Femoral & Provisional Impactor/Extractor
Zimmer Inc.
2011-04-18
2011-03-24 62540
Type II
00590102600
61522231, 61550613, 61637191, 61657309, 61659596
There is a potential for the spring clip of the NexGen Complete Knee Solution Femoral and Provisional Impactor/Extractor to break off during use and fall into the surgical site. Zimmer has received 24 complaints of the spring clip breaking, 4 of which were reported that the patient had to undergo additional x-ray to ensure the fractured clip had not been left in-vivo. There has been 1 report of the spring clip being found in-vivo during this process. These instruments (same lots) are already being recalled in relation to another issue (black coating falling off) - see recall number 62538. There is a potential safety risk related to patient treatment when using the portal review application of the Syngo RT Therapist. As a consequence of this risk, an incorrect offset may be applied for patient positioning and thus may result in a mistreatment (dose to wrong location). Mislabeled product. Inner and outer label of some lots labelled 'cementless' instead of 'for cemented use only.' A small number of access port needle accessory pouches from lot 9L01N may have a breach in seal integrity (voids across seal) that may result in the products no longer being sterile. The sample presentation unit ("SPU") may push two sample racks instead of one into the sample presentation area when the gap between racks is obstructed with foreign material such as tape. Beckman Coulter has received a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the two was not scanned. This is referred to as a "pushed pair."
A) Artiste MV-Linear Accelerator-Syngo RT Therapist Assist B) Artiste MV-Linear Accelerator-Syngo RT Therapist
Siemens AG
2011-04-18
2011-03-28 62573
Type III
A) 08162807 B) 08162815
A) 10024, 10048 B) 10003, 10040
Aequalis Fracture Stem Implant
Tornier
2011-04-18
2011-02-15 62613
Type II
DWB171, DWB172, DWB173
Lap-Band Access Port Needles
Allergan, Inc.
2011-04-18
2011-03-21 62572
Type II
B-20302-10
3566AJXXX, 4720AJXXX, 4721AJXXX, 4722AJXXX, 5346AJXXX, 2793AJXXX 9L01N
A) Unicel DXI 600 Access Immunoassay System - Instrument Class 2 B) Unicel DXC 880I Synchron Access Clinical Analyzer C) Unicel DXI 800 Access Immunoassay System - Analyzer Class II D) Unicel DXC 660I Synchron Access Clinical Analyzer E) Unicel DXC 860I Synchron Access Clinical Analyzer F) Unicel DXI 600 Access Immunoassay System - Instrument with Dual Gantry Class 2 iSite PACS
2011-05-02
2011-01-26 61295
Type II
A) A30260 B) 4768 C) 973100 D) 4771 E) 4773 F) A71461
A) A30260 B) A59102 C) 973100 D) A64871 E) A64935 F) A71461
Philips Healthcare Informatics, Inc.
2011-05-02
2011-03-23 62475
Type II
Version 3.X
N/A
When performing measurements on a volume value image (MIP, MPR, 3D), clinicians are able to take snapshots of their measurements in a capture window. If they do not save the capture window and they make measurement changes in the original image, it updates the measurement values in the capture window, but it does not update the associated graphics in the capture window. Thus, the measurement value no longer corresponds to the graphic displayed in the capture window. This could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.
IMPAX CV - Cardiovascular Review Station (CRS)
Agfa HealthCare
2011-05-02
2011-03-21 62606
Type II
60+00007791
N/A
If the end user does not follow Agfa's recommended XA measurement calibration technique, the resulting calibration may result in an imprecise XA measurement being obtained.
A) Bigliani/Flatow Shoulder IM Reamers B) TM Shoulder Instrument Distal Pilot Updated recall # 56687 previously posted on 2010-10-25.
Zimmer Inc.
2011-05-02
2010-09-17 56687
Type II
A) 00430100600, 00430100700, 00430100800, 00430100900, 00430101000, 00430101100, 00430101200, 00430101300, 00430101400, 00430101500, 00430101600, 00-4301-006/016-00, 00-4301-000-17/18 B) 00431000813, 00431000817, 00431000913, 00431001013, 00431001017, 00431001113, 00431001213, 00431001217, 00431001313, 00431001413, 00431001417, 00431001513, 00431001613, 00431001713, 00431001813
Integrated Reusable Fibre Optic Blade
BOMImed Inc.
2011-05-02
2010-11-04 58635
Type II
A) Non-DEHP Microbore Administration Set B) Microbore Administration Set C) Epidural Administration Set Visage 7 Software
Zevex Inc. Also trading as Moog Medical Devices Group
2011-05-02
2011-01-27 61461
Type II
OL-32D0, OL-32D1, OL-32D2, OL-32D3, OL-32D4, OL-32E0, OL-32E00, OL-32E1, OL-32E2, OL-32E3, OL-32E4 A) 340-4168 B) 340-4115, 340-4134 C) 340-4126 Visage 7.0X
0310, 0510, 2710, 3210
A) D100712 B) D004616, D008511, D010911 C) D010321, D010416, D013714, D015326, CF10120003, D016002, D017913 35300083
The distal reamers described are only affected by this recall when used with the Trabecular Metal Humeral and the Trabecular Metal Reverse Shoulder Systems. A Zimmer complaint investigation of these two systems suggests that surgeons may find that the trial stem fits appropriately, but the implant engages the humeral canal earlier than expected. As part of a Recall Update to customers, issued on March 29 2011, Zimmer notified customers of an error in the affected item numbers for the Distal Reamers provided in the previous communication ? They should have been identified as "00-4301-006/016-00 and 00-4301-000-17/18. " There is a potential issue with an aesthetic dot at the back of the blade. Potential for this dot to become loose or fall out after autoclave. This could occur on about 10% of all manufactured blades. May pose potential risk if not monitored. A defect with the resin used in tubing received from a supplier has been discovered. This has resulted in a rough texture on the inner and outer diameter of the tubing segment inserted into the pump. This could lead to the pump sensor registering an air bubble, causing an unresolvable false air-in-line alarm, even if no air bubble is present. During quality control and improvement process for Visage 7 software, two of specialized 2D measurement tools in some situations do not allow for manual pixel calibration and can lead to misleading results. Labels display incorrect load limit of 273 kg (600 pounds) instead of the intended limit of 227 kg (500 pounds). Stryker Endoscopy has discovered that the cleaning validation adoption for the inflow/outflow cannula was not effective at cleaning. There is a potential malfunction of the MLX control board attributed to an over riding jumperwire on repaired 300 watt power supply, which may not have been removed during repairs requiring a new replacement power supply. Certain lots of Con-Zellin Disinfecting Swabs included in individual Optimal-IT Kits could be contaminated with the bacillus cereus bacteria. Dimensional issues associated with the connector hub that is used to attach the device positioning unit to the detachment control cable. Loss of electrical conductivity can result in failure to detach a coil for deployment inside an aneurysm.
Visage Imaging GMBH
2011-05-02
2010-12-15 61551
Type II
35A Series Ambulance Stretcher IFU for Inflow/Outflow Cannula MLX 300 Watt Xenon Light Source
Ferno, Division of Ferno-Washington, Inc. Stryker Endoscopy Integra Radionics, Inc.
2011-05-02 2011-05-02 2011-05-02
2011-03-07 62159 2011-03-08 62215 2011-03-10 62480
Type III Type II Type II
N/A 0747-031-650 00MLX
N/A All lots N/A
Optimal-IT:Con-Zellin Disinfecting Swabs in Indivdual Test Kits Bio-Rad A) Micrus Endovascular Microcoil System -Presidio Microcoil PC4 B) Micrus Endovascular Microcoil System-Cashmere Model SRC C) Micrus Endovascular Microcoil System-Cashmere Model CRC D) Micrus Endovascular Microcoil System-Deltapaq-10 SR E) Micrus Endovascular Microcoil System-Deltapaq-10 Cerecyte F) Micrus Endovascular Microcoil System-Modified Cerecyte Microcoil - CSP G) Micrus Endovascular Microcoil System-Deltaplush 10 Cerecyte H) Micrus Endovascular Microcoil System- Deltaplush 10 Stretch-Resistant I) Micrus Endovascular Microcoil System-Micrusphere XL 18 Stretch-Resistant Micrus Endovascular Corporation
2011-05-02 2011-05-02
2011-03-29 62619 2010-10-25 58338
Type II Type II
710024 A) PC4100412-30, PC4100626-30, PC4100730-30, PC4180830-30, PC418093330, PC4181137-30, PC4181240-30 B) SRC140303-20, SRC140306-20, SRC140408-20, SRC140615-20, SRC14071720, SRC140922-20 C) CRC140306-30 D) DFS100152-20, DFS100154-20, DFS100156-20, DFS100203-20, DFS10020420, DFS100250-20, DFS100254-20, DFS100306-20, DFS100308-20, DFS10031020, DFS100408-20, DFS100410-20, DFS100510-20, DFS100616-20, DFS10071620, DFS100925-20, DFS101025-20 E) CSP100300-30, CSP100400-30 F) CPL100151-30, CPL100254-30, CPL100306-30 G) DPL100152-20, DPL100153-20, DPL100201-20, DPL100203-20, DPL10020420, DPL100206-20, DPL100254-20, DPL100256-20, DPL100304-20, DPL10030620, DPL100408-20 H) DPL100152-20, DPL100153-20, DPL100201-20, DPL100203-20, DPL10020420, DPL100206-20, DPL100254-20, DPL100256-20, DPL100304-20, DPL10030620, DPL100408-20 I) SSR180825-20, SSR181028-20, SSR181128-20, SSR181540-20, SSR18164020, SSR181740-20
0B0010, 0C0011M, 0E0016M, 0G0021M, 0J0026M, 0K0029M, 0K0030M A) f62328, g11109, g11154, g11102, g11131, g11140, g11106 B) >10 Numbers, Contact Manufacturer C) g10996, g11310 D) >10 Numbers, Contact Manufacturer E) g10987 F) g11062, g11180 G) g11053, g10962 H) >10 Numbers, Contact Manufacturer I) g11090, g11087, g11093, g11088, g11094, g11326
Marus Link Arm Assembly
Dental Equipment, LLC
2011-05-02
2011-03-07 62578
Type III
N/A
Catatalogue numbers DC1690, DC1700, DC1702, DC1235, DC1490 96485, 97325
The link arm assembly that connects some rear mounted accessories such as cuspidors and assistant's instrumentation to the DC1235, DC1490, DC1690, DC1700 and DC1702 dental chair models may break and fall off the dental chair. Outer label of Pitt Easy 3.75 mm diameter implants were correctly labelled as 3.0 mm locator abutment, however inner bag was incorrectly labelled as 2.0 mm locator abutment. Four complaints that dental impression material set too quickly. Therakos has received an increased rate of complaints related to leaks at tubing connections for certain lots of Therakos UVAR XTS Procedural Kits. Internal investigation has determined that a raw material used in the manufacture of the kit is causing leaks to occur in certain lots. When following a specific workflow in which operators (1) acquire data, (2) log out without analysing the data, and (3) log back in and acquire data for another patient, the exam data from the second patient may incorrectly be saved under the name of the first patient. Ethicon, Inc. is recalling multiple lots of Blake Drains, Blake Drain Kits, Blake Drains with Trocar, Blake Cardio Connectors, and J-VAC Reservoirs, with distribution dates of May 10, 2010 to present. The company has identified the potential for the sterile barrier of the product packaging to be compromised after receiving customer complaints.
Zest Locator Abutment Pitt Easy 3.75mm
Zest Anchors, LLC Also trading as Zest Anchors, Inc. and Zest Anchors Pentron Clinical Technologies, LLC Therakos, Inc.
2011-05-02
2010-11-20 59635
Type III
08323P
Correct Quick Extra Light Therakos UVAR XTS Procedural Kits
2011-05-02 2011-05-02
2011-02-20 61879 2011-04-04 62673
Type III Type II
N/A XT001, XT125
197937 >10 Numbers, Contact Manufacturer
A) Cirrus HD-OCT B) Cirrus HD-OCT Model 400
Carl Zeiss Meditec Inc.
2011-05-02
2011-03-14 62637
Type III
A) 4000 B) Model 400
A) N/A B) N/A
A) J-VAC Reservoir B) Blake Drain Kit C) Flat Blake Silicone Drains 3/4 Fluted without Trocar D) Flat Blake Silicone Drains 3/4 Full Fluted without Trocar E) Flat Blake Silicone Drains Full Flued with Trocar F) Flat Blake Silicone Drains 3/4 Fluted with Trocar G) Round Blake Hubless Silicone Drains without Trocar H) Round Blake Hubless Silicone Drains with Trocar I) Blake Cardio Connector
Ethicon Inc.
2011-05-02
2011-04-05 62679
Type II
A) 2160 B) 2207, 2236, 2238 C) 2210, 2213 D) 2211, 2214 E) 2212 F) 2216, 2217 G) 2226, 2228, 2230, 2234 H) 2227, 2229, 2231, 2232, 2233 I) BCC1, BCC2, BCC3
A) J100214, J100720, J101307, W00024418, W00025494 B) J103604, J101046, J101047, J103586, J100440, J103590 C) W00025507, J100174, J100011, J101607, J108130, J100140, J101503, J102391 D) J100665, J100079, J100080, J100672, J101527, J1015775, J102897, J103976, W00025526 E) J101270 F) J100010, J101249, J101511, J100183, J101518, J104968, J108182, J108183, W00024310 G) >10 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer All lots
Process System Manager (PSM) Software
Roche Diagnostics Ltd.
2011-05-02
2011-04-04 62746
Type I
04944607001
Result mix up that can occur when sample IDS (barcode number/tube identifier) are repeated in the Process System Manager (PSM) database and results are manually resent to the hospital host system (laboratory information system (LIS)). The manufacturer has determined through internal testing that the circuit that supplies backup power to the modules is not working. If there is a power interruption, the 3-minute backup may not be operational and you may lose any changes you have made to the alarm settings. When used with model 91387, the hazard presents a risk for all modules except modules 90470, 90478, 90496 & 91496, all of which have their own internal backup and will not lose changes to the alarm settings for power interruptions less than 3 minutes. This recall has been initiated due to product containing Triad alcohol and iodine pads. Triad Group is reporting a potential contaminant in the alcohol and iodine pad that can possibly cause a rash or skin infection. During incoming inspection of the Filterline H Set Infant Neonatal CO2 sampling line by a distributor, plastic strands with a typical length of 0.5 cm and a diameter of 100 microns were found on the inner side of the adapter. This recall supersedes Teleflex's March 4, 2011 communication. Teleflex Medical is withdrawing the Rusch Irrigation Trays catalogue number 67890 and 68895 from the market. These trays contain alcohol prep pads recalled by Triad due to concern about bacterial contamination. All trays containing the alcohol prep pads recalled by Triad should be returned to Teleflex Medical. Ortho Clinical Diagnostics (OCD) has determined that some dilution factors configured on the enGen Laboratory Automation System are not supported in the instructions for use for the following 4 OCD Vitros Products: Vitros CHE Slides, Vitros CRBM Slides, Vitros TIBC Kit, and Vitros UPRO Slides. To address this, OCD will implement a software modification that will remove all non-supported dilution factors on the enGen System. It is no longer a recommended option to implant a pace-sense lead while maintaining use of the Fidelis high voltage conductors after a Fidelis pace-sense conductor fracture has occurred.
Spacelabs Medical Patient Monitor, 91387
Spacelabs Medical, Inc.
2011-05-02
2011-04-11 62752
Type II
91387
Arterial Blood Gas Sampling Kit
Westmed, Inc.
2011-05-02
2011-01-03 62597
Type I
3373, 3373-95
N/A
A) Vitaline H Set Infant/Neonatal 25UN B) Filterline H Set Infant/Neonatal Urethral Procedure Tray With Syringe
Oridion Medical 1987 Ltd.
2011-05-02
2011-03-25 62748
Type II
A) 010807 B) 006324 67890, 68895
A) M8535B11 B) M8544B11 >10 Numbers, Contact Manufacturer
Teleflex Medical
2011-05-02
2011-04-06 62758
Type II
2011-05-02
2011-04-08 62760
Type III
enGen
JCT20Q3J, J16XQH4J, JIHX7S4J, J41BCY4J
A) Sprint Fidelis Steroid Eluting Quadripolar Vent. B) Sprint Fidelis Steroid Eluting Tripolar Vent. C) Sprint Fidelis Steroid Eluting - Quadripolar D) Sprint Fidelis Steroid Eluting - Tripolar
Medtronic Inc.
2011-05-02
2011-04-01 62706
Type III
A) 6949 B) 6931 C) 6948 D) 6930
A) >1000 Numbers, Contact Manufacturer B) >1000 Numbers, Contact Manufacturer C) >100 Numbers, Contact Manufacturer D) LFK004993V, LFK004820V, LFK004984V, LFK005530V, LFK001689V, LFK003047V, LFK001690V, LFK004992V A) >1000 Numbers, Contact Manufacturer B) >1000 Numbers, Contact Manufacturer 1010194
A) Sprint Quattro Secure S Ventricular Lead B) Sprint Quattro Secure Quadripolar Lead Adult R2 Non-Radiolucent Electrodes
Medtronic Inc. Conmed Corporation
2011-05-02 2011-05-02
2010-10-26 59071 2011-03-31 62596
Type II Type II
A) 6935 B) 6947 3200-1715
Possible over-retraction of the helix beyond the retraction stop could occur, which may result in the inability of the helix to extend in subsequent attempts. Catalogue number 3200-1715, lot 1010194, were assembled without the white oval shield which covers the wire set's rivet connection to the electrode pad. If the white rivet cover is missing, the metal rivet is exposed. bioMerieux distributed a product correction notice in September 2010 regarding the performance of piperacillin/tazobactam (TZP) with E.coli and K.pneumoniae on the Vitek 2 gram negative susceptibility test cards. Further performance testings revealed overcalling resistance issues for additional species. These species include, E.coli, K. pneumoniae, M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P. aeruginosa, S. enterica. The indicator cells of this lot continue to show acceptable reactivity when used for testing according to the package insert, however, weaker reactions have been observed with the Capture-CMV positive control serum (weak). Wrinkles in Ca++ membrane unit foils can cause biassed measuring results.
A) VITEK 2 Compact 30 System B) VITEK 2 Compact 60 System C) Vitek 2 / Susceptibility test Cards
bioMerieux, Inc.
2011-05-02
2011-04-04 62767
Type II
Capture-CMV Indicator Red Cells
Immucor Inc.
2011-05-02
2011-04-11 62791
Type II
A) 22214, 22224, 22225, 22227, 22228, 22229, 22230, 22244, 22245, 22246, 22250, 22293, 22295, 410101, 410102 B) 22214, 22224, 22225, 22227, 22228, 22229, 22230, 22244, 22245, 22246, 22250, 22293, 22295, 410101, 410102 C) 22214, 22224, 22225, 22227, 22228, 22229, 22230, 22244, 22245, 22246, 22250, 22293, 22295, 410101, 410102 0062791
A) All lots B) All lots C) All lots
228143
Ca++ membrane code 942-060
Radiometer Medical ApS
2011-05-02
2011-04-07 62795
Type II
942-060
All lots Since September 2010.
A) Diagnost 97 B) Diagnost 94
Philips Medical Systems Nederland B.V.
2011-05-02
2011-04-04 62796
Type II
A) MII 3061, MRC 0651 B) 70850, 70851
A) N/A B) N/A
During examination, if the patient is positioned with his knees pointed to the rear of the system and the operator performs a wrong movement of the scanning beam, downwards instead of upwards, the leg(s) of the patient might collide with the stand and get squeezed, potentially resulting in a (serious) injury. There is a potential for early component failure. The system board in the Hewlett-Packard RP5700 computer contains electrolytic capacitors that may fail prematurely, causing the computer to malfunction. It is also possible that the display may "freeze". Philips has become aware that some PAS-210 active speaker assemblies in use with the Philips Intellivue Information Center (PIIC) have experienced intermittent audio or loss of audio. After investigation, it was determined that the speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system, e.g., a bedside monitor. This may result in delayed treatment of the patient. The Xeleris thyroid uptake index operator manual seems to be inadequate since customers are confused about the correct procedures or not performing it correctly, including not using the calibration factor. Under certain circumstances, edits to an order can result in unintended scheduled interventions on the Intellivue Clinical Information Portfolio. If the clinical team does not recognize that extra scheduled interventions exist, a patient may receive interventions or additional medication doses that are not intended. Unlicensed class III device - notification to distributors. OneTouch Zoom Pro Diabetes Management Software has an incompatibility issue with Microsoft MSXML4 service pack 1. When this program interfaces with OneTouch Zoom Pro Diabetes Management Software it can cause device blood-glucose values under specific circumstances, to be displayed in numbers that are significantly higher than their true mmol/l values. There is one mislabeled lot of this product. Some of the refill bags of the OptiBond FL Adhesive contained the OptiBond FL Primer bottle. Microfuge Administration Sets sold without medical device license prior to October 7, 2010. Possibility of sparking, charring & fires from the power cords because the power cord's prongs may crack & fail at/or inside the plug.
Intellivue-Information Center
2011-05-02
2011-04-04 62798
Type II
M3150, M3155
N/A
Intellivue-Information Center
2011-05-02
2011-04-04 62799
Type II
M3150, M3155
N/A
A) Xeleris 2 Workstation Imaging System B) Xeleris Nuclear Medicine Workstation
GE Medical Systems Israel, Functional Imaging
2011-05-02
2011-01-11 56796
Type III
A) H3900JH, H3900NM, S8006KA/KB/KC/KD B) H3700JA/JB/KA/KB
Intellivue Clinical Information Portfolio
Philips Medizin Systeme Boeblingen GMBH
2011-05-02
2011-04-04 62797
Type II
All lots
Nanolight MP50 Sybaritic Inc. Global Aesthetic Solutions OneTouch Zoom Pro Diabetes Management Software Version LifeScan Inc. 5.1
2011-05-02 2011-05-02
2011-03-08 62866 2011-04-18 62887
Type II Type III
404208-MP, 404208-MPG 022-151
All lots A-58277
OptiBond Adhesive Refill Microbore Administration Set A) Bio-Console Drive Unit (550) B) Autolog Autotransfusion System C) Bio-Console Drive Unit (560) D) Magellan Autologous Platelet Separator
Kerr Corporation Baxa Corporation Medtronic Inc.
2011-05-02 2011-05-02 2011-05-02
2011-03-16 61848 2010-10-15 62929 2010-04-28 54391
Type II Type III Type II
25882 N/A A) 95208 B) ATLG110 C) 560 D) MAG100
3447051 All lots till October, 7 2010. A) 8473, 8466, 8687, 8607, 8729, 8622, 8184, 8677 B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) MAG1001017, MAG1000592, MAG1000043, MAG1000506, MAG1000249, MAG1000644, MAG1000019, MAG1000597, MAG1000594 HIT0040, HIT0606M, HIT0606RI, HIT0716
Aria Software (Version 6.5)
2011-05-16
2011-02-18 62920
Type II
Vision (Version 6.5)
An anomaly was identified in the Aria Versions 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (completely irradiated aperture opening) is calculated, the resulting CIAO display at 4DITC may be wrong. This results in a CIAO which is in many cases larger than the actual largest extent of the irradiated area - possibly leading to an unintentional gap if that outline is used for edge matching of a second field. The Soft-Core Endodontic Obturator procedure packs contained a size #25 obturator rather than the correct size #30 obturator. Potential for failure for users to provide an obstacle free service path outside the 200g field & not having another trained person on site, resulting in death or serious injury to service engineers. If gradient cables are inadvertently swapped while servicing and geometry check not performed as required in procedure, images may be flipped left-right with incorrect orientation annotation. The identified lot of SPoT-Light HER2 CISH Kit includes SSC buffer that may be contaminated with acremonium strictum, a fungal contaminant. This incident was identified through a customer complaint. This customer also reported a weaker staining, however, inhouse testing of the buffer with the kit indicated that the kit continues to perform as intended. When attempting to remove inserter from the stem, the inserter may become stuck, not allowing it to disengage from the stem. Ortho Clinical Diagnostics received a customer complaint regarding the loss of calibration data following the installation of a development-only assay data disk (ADD), data release version (DRV) 9241 or 9251, that was available in the on-screen mailbox on the main menu system status screen of their Vitros 5600 Integrated System. Dash Monitor may show reboots on some networks when 802.11B wireless LAN option used to connect to hospital wireless LAN infrastructure, resulting in loss of patient monitoring, patient alarms & vital signs data. Labelling error. Box is labelled 972-2435, .04 taper points, but outer bag is labelled 9722235, .02 taper points. Actual contents are 972-2235. Collimator cover is falling from the linear accelerator. It appears the collimator cover was not properly installed and that motion of the linear accelerator caused the cover to detach and fall from the machine. It was determined that the collimator latching mechanism may be difficult to latch properly, resulting in an increased likelihood of accidental detachment of the collimator cover.
Soft-Core Classic Endodontic Obturator Signa HDE 1.5T MRI System - Magnet
Ormco Corporation, Also trading as Sybronendo GE Healthcare Japan Corporation
2011-05-16 2011-05-16
2011-03-14 61830 2010-12-15 56973
Type III Type II
ESC-03006CL M3335SE
081006701 All Serial Numbers
Signa HDE 1.5T MRI System - Magnet
GE Healthcare Japan Corporation
2011-05-16
2010-12-15 57846
Type II
M3335SE
All Serial Numbers
SPoT-Light HER2 CISH Kit
Invitrogen Corporation
2011-05-16
2011-04-18 62851
Type III
84-0150
849398A
Comprehensive Primary & Fracture Shoulder Stem Inserter Vitros 5600 Integrated System
Biomet Orthopedics Ortho-Clinical Diagnostics Inc.
2011-05-16 2011-05-16
2011-04-07 62868 2011-04-14 62869
Type II Type III
31-406901, 407398 680 2863, 680 2864
525360, 293840, 299010, 401810 56000124, 56001005
A) Dash 3000 Patient Monitor B) Dash 5000 Patient Monitor C) Dash 4000 Patient Monitor RealSeal .02 Taper Points A) Clinac Linear Accelerator B) Clinac IX High Energy Linear Accelerator C) Trilogy High Energy Linear Accelerator D) Novalis TX High Energy Linear Accelerator E) Clinac 2100C High Energy Linear Accelerator F) Clinac 21EX High Energy Linear Accelerator G) Clinac 23EX High Energy Linear Accelerator
GE Medical Systems Information Technologies, Inc. Ormco Corporation, Also trading as Sybronendo Varian Medical Systems, Inc.
2011-05-16
2011-04-21 62636
Type II
2011-05-16 2011-05-16
2011-02-21 61845 2011-03-17 63079
Type III Type II
A) DASH3-XXXX-XXXX-XXXX B) DASH5-XXXX-XXXX-XXXX C) DASH4-XXXX-XXXX-XXXX 972-2235 A) 600C, 6EX B) Clinac IX C) Trilogy D) Novalis TX E) 2100C F) 21EX G) 23EX
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer 190901 A) H180796 (6EX Unit), H180605 (600C Unit), H180600 (600C Unit), H291180 (600C Unit), H293787 (600C Unit), H272910 (6EX unit), H180619 (6EX Unit), H180683 (6EX Unit) B) >10 Numbers, Contact Manufacturer C) H272158, H272283, H180601, H293908, H293509 D) H272857 E) H272118, H271662, H271663, H272858 F) >10 Numbers, Contact Manufacturer G) H291172 10k291 166859, 172112, 179105, 185567, 174980
TMA Archwires Artiste Nano-Hybrid Flowable Composite
Ormco Corporation, Also trading as Sybron Implant Solutions Pentron Clinical Technologies, LLC
2011-05-16 2011-05-16
2011-04-26 63143 2011-04-20 63139
Type III Type III
211-1402 N28F, N28VF, N28VXA
Mispackaging of TMA Archwires. Packages labelled with 211-1402 (TMA broad arch .016 x .022 lower) actually contained 202-1007 (TMA upper arch .017 x.025) Artiste Flowable is difficult to extrude. Production records confirmed that product was released out of specification for viscosity. Additional lots added to initial recall.
Colleague Volumetric Infusion Pump
2011-05-16
2011-04-14 63119
Type II
DNM9161
20110002JF, 20110004JF, 20110005JF, 20110007JF, 20110010JF, 20110001JF
Flow Set Fluorosphere
2011-05-16
2011-04-25 63160
Type II
6607007
7524013F
Solution packs to ABL80 Basic/Flex
Radiometer Medical APS
2011-05-16
2011-04-18 63213
Type III
944-174, 944-309
TEG 5000 Hemostatis Analyzer
Haemonetics Corporation DBA Haemoscope Corporation
2011-05-30
2011-01-24 62582
Type III
5000
62718, 62784, 62871, 63038, 63134, 63390, 63480, 63620, 63718, 63864, 62785 All lots
Baxter has determined that there is a potential soldering defect with a single component identified on a limited number of UIM PCBA (user interface module printed circuit board assembly) received from their PCBA supplier/manufacturer. This issue is limited to the Colleague Pump serial numbers listed. This soldering defect could lead to a delay or interruption of therapy. Beckman Coulter has identified that Flow-Set Fluorospheres, part number 6607007, lot 7524013f, table of application target settings sheet has mislabeled target values for stemONE and stemCXP. Affected lots of Solution packs were produced with a wrong conductivity value encoded into the chip. This causes a minor negative bias for the HCT (hematocrite) measurement of 1 to 2% and following failure of the air detection system. Letter to customers advising on proper connection and handling of the power source after a product complaint. If the DIN4 connector is removed before removing the power supply from the electrical outlet and if the DIN4 connector made contact with metal, the unit will heat and smoke. The thermal fuse would open however to mitigate any risk. Potential safety risk related to the behaviour of the 160 mlc when using the 'motion stop' button followed by `reset' several times during the treatment of one beam or one segment. As a consequence of this mlc behaviour, the leaf positions may vary from the originally prescribed position. Therefore the remaining MU for the beam or segment may be applied to an incorrect field size and thus could result in a mistreatment (dose to wrong location). Coulter ReticPrep Reagent Kit, PN 7546978, lN 108901K components were packaged into an undetermined quantity of cartons labelled as lN 108900K. Beckman Coulter Inc. identified an issue with one of the raw materials used to manufacture the COULTER Ac T 5diff Fix Reagent, lots: 16602E, 16702E, and 16802E. . It was determined that fine plastic strands inside the endotracheal tube side of the airway adapter may become dislodged and subsequently inhaled by the patient. The strands are typically 5mm long and 100 microns in diameter, about the thickness of a human hair.
ARTISTE, ONCOR with 160-MLC
Siemens AG
2011-05-30
2011-04-19 63083
Type III
8139789
5414, 5485
ReticPrep Reagent Kit COULTER Ac T 5diff Fix Reagent
Beckman Coulter, Inc. Beckman Coulter, Inc.
2011-05-30 2011-05-30 2011-05-30
2011-04-08 63103 2011-04-11 62846 2011-04-13 63014
7546978 N/A A) M1923A B) 9898031 59581 C) M3015A D) M3015A
108901K 16602E, 16702E, 16802E A) N/A B) N/A C) N/A D) N/A
A) Viridia Component Monitoring System Philips Medizin Systeme Boeblingen GMBH B) Filterline Set H Infant / Neonatal C) Intellivue MP30 Patient Monitor System-Microstream Co2 Extension D) Intellivue MX800 Patient Monitor System-Microstream Co2 Extension Total Iron Binding Capacity (TIBC) Assay Siemens Healthcare Diagnostics Ltd.
2011-05-30
2011-04-15 63097
Type III
3940010
V43197
Zenith AAA Endovascular Graft
Cook, Inc.
2011-05-30
2011-04-20 63110
Type II
TFLE-10-71-ZT
2696926
IMMAGE 800 Immunochemistry System
2011-05-30
2011-04-25 63125
Type II
A15445
Waters IEEE Detector
Waters Corporation
2011-05-30
2011-03-25 63353
Type III
2487
C06487243M, M06487017M
BiteProof Bite Blocks, Part #11040
B & B Medical Technologies
2011-05-30
2010-03-31 55384
Type II
Part #11040
D816804
ReliaMed Deluxe Portable Adjusting Table
Huangshan City Shexian Comfort Massage Appliance Company Ltd. Teledyne Instruments, Analytical Instruments
2011-05-30
2010-04-23 59698
Type II
ZZRMT100BL (Blue), ZZRMT100BLK (Black)
N/A
Oxygen Sensor/R-15
2011-05-30
2010-12-07 60029
Type II
R-15
617654, 617655, 617656
A) Dual Blue-Release Adult Walker-Wheeled B) Blue Release Junior Walker with 5" Fixed Wheels
Invacare Corporation
2011-05-30
2011-03-25 62607
Type II
A) 6240-5F B) 6240-JR5F
A) HP XXXXXX B) HP XXXXXX
Unicel DXH 800 Coulter Cellular Analysis System
2011-05-30
2011-04-11 63028
Type II
629029
All lots / Tous les lots
The Advia Chemisty Systems 1200, 1650, 1800 and 2400 TIBC Reagent (lot V43197) was mislabeled with an expiration date of 18 months that exceeds the true expiration date of 12 months. One lot number is being recalled in Canada due to the receipt of information that indicates there may be potential damage to the braided suture which is used to attach the external stent to the graft material. The catalogue number (cat no) listing on the IMMAGE 800 name rating plate label is incorrect for units with serial numbers: 9081 - 9171, 9176 - 9178. The cat no should be A15445, but is listed as A15455 because of a typographical error. All information on the label other than the cat no is correct. Potential exists for some data points within the 2D chromatogram to be missing due to signal dropout. This is evident with the Waters IEEE Detector and associated Empower software. The plastic arm that connects the sticky tab to the bite block itself has a thin area of plastic just where the bite block connects. The bite block separated from the sticky tab at this thinner area. MDC has received 3 complaints involving table breakage during use. Each complaint involved reports of breakage of the vinyl-covered, padded, plywood table surface near the foot end. No actual injury occurred in any of the complaints. American customers discovered electrolyte breach resulting in discolouring of sensor on class R15 oxygen sensors. Company investigation revealed some sensors had a deeper and slanted chamfer on the sealing cylinder hole that may have resulted in compromised sensor seal. This product is being recalled because the caster bolt on the wheeled extension is too short to adequately maintain the nylex fastener, resulting in potential caster loosening and increased likelihood of the caster falling off of the walker. This has the potential to create unexpected user instability. Beckman Coulter has the following issues with the Unicel DXH 800 Coulter Cellular Analysis System: 1.Auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old. 2.The last set of results for each panel analyzed without demographics will always be saved. 3.The DXH 800 may intermittently fail to transmit the correct control files, or partially transmit the number of control files requested, to the interlaboratory quality assurance program ("IQAP") through the remote management system (RMS). 4.The DXH 800 exports control data intended for interlaboratory quality assurance (IQAP) in the reporting units configured by the customer. IQAP is expecting to receive those results in one standard format. The ACCESS HAV Ab assay of product lot exhibits inconsistent patient dose response. This inconsistency may be manifested by erroneously low or high QC/sample dose results that could cause incorrect qualitative classification (i.e. false positive, false negative, false equivocal results) for the patient. If a 12 lead ECG is recorded and the user restarts ECG monitoring quickly (e.g. if the recorded ECG is viewed for less than 13 seconds) then the ECG can cease operating. This issue can present itself either as a monitoring view with no ECG lead traces shown on the display of (more likely) as a leads-off condition on all leads in monitoring mode. In this case ECG monitoring is suspended. We have identified an unusual condition under which the E Series BLS Defibrillator can display a shock advised message but not auto-charge the defibrillator. Failure to autocharge the defibrillator could delay delivery of therapy. Boxes of Liquichek Hematology 16 Control (Low, Normal and High) master lot 76770 may contain vials of Liquichek Hematology 16 Control (Low, Normal and High) master lot 76760. Unlicensed device sold.
ACCESS HAV Ab
2011-05-30
2011-03-29 63094
Type II
34200
94059, 94060
Tempus IC Patient Monitor
Remote Diagnostic Technologies Limited
2011-05-30
2011-03-22 63234
Type III
00-1001
000418, 000443, 000467
Zoll E Series BLS Defibrillator
Zoll Medical Corporation
2011-05-30
2011-04-21 63242
Type II
Zoll E Series
Software Version 7.10 of 7.11
Liquichek Hematology 16 Control (Low, Normal & High) A) Ultra Zone 3 Air Mattress B) Ultracare 10 Air Mattress
Bio-Rad Laboratories T.H.E. Medical
2011-05-30 2011-05-30
2011-04-19 63257 2011-04-20 63320
Type II Type III
760, 761, 762, 763 A) TD1002 B) TD1004
76771, 76772, 76773, 76770 A) N/A B) N/A
2011-05-30
2011-04-29 63392
Type II
enGen
JCT20Q3J, J16XQH4J, JIHX7S4J, J41BCY4J
Luminos DRF
Siemens AG
2011-05-30
2011-04-06 63437
Type III
10094200
2001
Ortho Clinical Diagnostics has received complaints of centrifuge buckets (part number 4412R) disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC robotic centrifuges (models 4815, 4816 and 4817), that may be configured with enGen Laboratory Automation Systems. Centrifuge bucket disconnections may result in damage to the Hettich centrifuge. This update instruction provides multiple bug fixes and system improvements, such as, enhanced direct radiation detection leading to wrong window values, wrong PEX-settings for spatial frequency parameters leading to black images, imaging system crash with cancel of reject analysis window, wrong flags in patient list, improvement of auto delete function, improvement of error 3070/032, and improvement of error 7031/032. GemStar devices utilizing the PC application are capable of being programmed for a bolus lower lockout limit interval less than the programmed hard limit value stored in the GemStar SP Infusion Suite Database PC application. This could potentially result in the infuser granting more frequent bolus delivery requests than intended in programming the hard limit potentially causing over-delivery of medication to the patient. The recalled lots were made in the same facility as other wipe products, including wipes, swabs and swab sticks, that are the subject of other voluntary recalls due to a potential bacterial contamination issue. There is potential for solvent to leak at the atmospheric pressure ionization (API) source and ingress into the instrument. There is a remote possibility that the solvent will ignite creating a potential fire hazard. This issue resulted from a design change. There have been no reports of solvent ignition in the field. If ignition were to occur, it is unlikely that the fire would be able to self sustain. The CUSA EXcel family of ultrasonic tissue ablators are used in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable. The EXcel family of devices is tested against standard 60601 for electrical safety, fire and mechanical hazard compliance by Underwriters Laboratory (UL) against European standard, UL and Canadian requirements. However, the three EXcel consoles that have been imported and distributed in Canada do not have the required specific UL Canada logo. Three lots manufactured between December 2, 2010 and December 6, 2010 that subsequently tested positive for high background tests. Safety advisory notice to inform the users about a potential issue related to patient treatment with table offsets on Syngo RT Therapist 4.1 and 4.2. as a consequence of this issue, an incorrect offset may be applied for patient positioning and thus may result in dose being delivered to the wrong location. The retaining ring portion of the manual addition port may become detached upon removal of the additive port cap. Detachment of the retaining ring can dislodge the septum and the bag may leak. An OrthoPAT System experienced a blood spill in the centrifuge area. During the cleaning process, fluid was used to irrigate the centrifuge area. The blood spill drain bag was not deployed correctly resulting in the drain system to malfunction, and fluid to overflow from the centrifuge well into the device closure. The current GLUCM (glucose modular) assay is not capable of reporting accurate results below 10mg/dl on both the LX and DXC systems. There is no discernable trend and the magnitude of the discrepancy is variable. GLUCM (glucose modular) assay is utilized on plasma, serum, urine and CSF samples. The current sensitivity claim for the assay is 3 mg/dl for all sample types. A method comparison across all Inhibin A formats and calibrations conducted revealed a +30% difference in patient dose response for the ELISA Kit when compared to the access. The Staph Latex Test Reagent in the kit is auto-agghlutinating making the product unusable. (i.e. agglutionation of the latex particles is occurring without the addition of the test organism). Update should help to recognize faulty gradient cable connections and subsequently prevent those from overheating. Oridion Medical,the manufacturer of Filterline products has discovered an issue with specific lots of the Filterline H Set Infant / Neonatal (part 006324) distributed with Nellcor(Covidien) N85 monitor kits. The issue concerns the presence of fine plastic strands inside the endo-tracheal tube side of the airway adapter which may become dislodged and inhaled by the patient. The purpose of this action is to inform physicians who have implanted or follow patients implanted with dual chamber pacemakers about a rare, approximately 1 in 18,000 devices, measurement lock-up condition that may inappropriately trigger ERI / RRT in specific Medtronic dual chamber pacemakers. In rare instances, these devices exhibit a condition in which the hardware component of the measurement system may lock up, resulting in the device declaring ERI (elective replacement indicator) / RRT (recommended replacement time). This device then inappropriately defaults to an ERI state. When devices exhibit this condition, they do not actually have a depleted battery, but rather the device displays ERI due to the erroneous voltage measurement. When the false ERI occurs, the device is reverted to a defined set of parameters (VVI mode at 65 beats per minute). A device exhibiting this condition can be resolved through the use of a specially configured programmer and software reset application to clear the ERI / RRT condition. The IPG is not modified, but simply returned to its previous settings. It should be noted that this issue does not shorten the actual device longevity after a reset.
GemStar SP Infusion Suite Database PC
Hospira Inc.
2011-05-30
2011-03-24 62617
Type II
13092
72613G1, 84832G1
Skin Prep Wipes
Smith & Nephew Inc. Wound Management Division Waters Corporation
2011-05-30
2011-04-12 62939
Type II
N/A
OG117, OG225, OJ146, OJ147, OK78, OM198
Waters Mass Spectrometer TQD
2011-05-30
2011-05-04 63482
Type II
N/A
QBB1050
CUSA EXcel + System
Integra LifeSciences (Ireland) Limited
2011-05-30
2011-04-15 63100
Type II
CUSA EXcel2
HFL1004101IE, HFB1100401IE, HFL1004701IE
Stromatolyser-IM Syngo RT Therapist
Sysmex Reagents America Siemens AG
2011-05-30 2011-05-30
2011-04-14 63134 2011-03-31 63454
Type II Type III
SIM-220A 08162815
Y0053, Y3354, Y0055 10003, 10040
ExactaMix Empty EVA Container
Baxa Corporation
2011-05-30
2011-03-08 63483
Type II
737, 738, 739, 740, 741
All lots since 2009/07/23.
OrthoPAT System
Haemonetics Corporation
2011-05-30
2011-04-29 63498
Type II
1050-110-ENG, 1050-240-FRN
00001 - 02279-T, 02280-T
Synchron Systems Glucose Reagent
2011-05-30
2011-04-21 63159
Type II
472500
All lots
ACTIVE Inhibin A ELISA
2011-05-30
2011-04-26 63161
Type II
10-28100-1, 10-28100-4
Prolex Staph Latex Kit
Pro-Lab Diagnostics
2011-05-30
2011-04-15 63296
Type III
PL80B, PL81B
C7992, C7912, C8048, C8117
A) MAGNETOM Symphony A Tim System Upgrade B) MAGNETOM Symphony MRI System C) MAGNETOM Sonata MRI System Filterline H Set Infant / Neonatal in N-85 Monitor Kit
Siemens AG
2011-05-30
2011-04-28 63452
Type II
Covidien LLC
2011-05-30
2011-04-13 63252
Type II
A) 10018223 B) 07104594, 07106557 C) 07104719, 07106425 N-85
A) 37223, 37227 B) >10 Numbers, Contact Manufacturer C) 21118, 21130, 21136, 21158, 21913 >10 Numbers, Contact Manufacturer
A) Adapta Dual Chamber Rate Responsive Pacemaker B) Versa Dual Chamber Rate Responsive Pacemaker C) Sensia Dual Chamber Rate Responsive Pacemaker D) Relia Dual Chamber Pacemaker E) Relia Dual Chamber Rate Responsive Pacemaker F) Kappa 700 KDR Dual Chamber Pacemaker G) Kappa 700 KD Dual Chamber Pacemaker H) Dual Chamber Rate Responsive Pacemaker I) Dual Chamber Atrial / Ventricular Sensing Pacemeker J) Enpulse Dual Chamber Rate Resposive Pacemaker K) Enpulse Dual Chamber Pacemaker L) Enpulse Dual Chamber Atrial / Ventricular Sensing Pacemaker
Medtronic Inc.
2011-05-30
2011-04-04 63274
Type II
A) ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADVDD01 B) VEDR01 C) SED01, SEDR01, SEDRL1 D) REVDD01 E) REDR01 F) KD703, KDR706 G) KD703, PHM621259S H) KDR803, KDR903, KDR906, KDR931, KDR933 I) KVDD901 J) E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33 K) E2D03 L) E2VDD01
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer G) >10 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer J) >10 Numbers, Contact Manufacturer K) >10 Numbers, Contact Manufacturer L) >10 Numbers, Contact Manufacturer
COBAS AmpliPrep / COBAS TaqMan HCV Test A) Liason Analyzer Class III B) Liason Analyzer Class 2
Roche Molecular Systems, Inc. Diasorin Inc.
2011-05-30 2011-05-30
2011-04-14 62989 2011-04-27 63449
Type II Type II
N/A A) 15970 B) 15970
All lots A) All lots B) All lots
Under-quantitation of a subset of genotype 4 patient specimens (by approximately 1.0 to 1.5 log10) in the absence of any sequence mismatches. During the manufacture of Liasion Analyzers two dilutor syringes malfunctioned. The glass body of the syringe became detached from the metal collar. The defect does not affect all dilutor syringes and all reported failures in the field have occurred within a week after installation, during routine use.
Aquilion 64 System
2011-05-30
2011-04-26 63539
Type II
TSX-101A/E, TSX-101A/EX, TSX-101A/H, TSX-101A/HX
ECA0552037, ECA05Z2249, HCA0642155, HCA06Y2410, HCA06Z2467, HCA0782875, HCA07X2919, HCA07Y3000, HDA0632105 A) >10 Numbers, Contact Manufacturer B) H294934, H294403, H294750, H293883, H291172, H140836, H294134, H293787, H294551, H291166 C) >10 Numbers, Contact Manufacturer D) H294674 174207, 174758 3564518 A) 26310F, 29910D B) 09710K, 09510T, 24210N, 28410J, 16610E, 18610G, 21010E, 27810D C) 10310N, 11410E, 00811N, 09510N, 30310H, 35510H D) 00811K, 09510U, 27210D, 27710W, 28410H, 29210F, 29210P E) 2011010746, 2010122387, 2011010747 A) All lots B) All lots 1027481 A) All Serial Numbers B) All Serial Numbers
In systems with the ECG modulation function, which permits the tube current to be adjusted in synchronization with the ECG waveform, it has been found that in CT examinations using this function, X-ray output may not be varied as specified. As a result, an error may occur and scanning may be interrupted. An anomaly has been identified for type 3 hard wedges whereby the labelling on the wedge tray may not correctly match the wedge body. For example, a 45 degree wedge body mounted on a tray labelled "60 degrees" or a 15 degree wedge body mounted on a tray labelled "30 degrees". In all cases the wedge body is labelled with the correct wedge angle.
A) Varian Clinac Linear Accelerator B) Trilogy Radiotherapy Delivery System C) Clinac IX Radio Therapy Delivery System D) Novalis TX Linear Accelerator
2011-05-30
2011-02-24 63660
Type II
A) 2100C, 21EX, 21EXD, 21EXDS, 21EXS, 23EX, 600C, 600N, 6EX B) Trilogy C) Clinac IX, Clinac IXS D) Novalis TX
Correct VPS Light Extra Body Build-it FR model # A3 A) Renasys G Gauze Dressing Kit - Complete Wound Drainage Kit B) Renasys G Gauze Dressing Kit with Round Drain C) Renasys G Gauze Dressing Kit with Flat Drain D) Renasys G Gauze Dressing Kit with Channel Drain E) Renasys G Gauze Dressing Kit with Port
Kerr Corporation, Also trading as Pentron Clinical Pentron Clinical Technologies, LLC Smith & Nephew Inc. Wound Management Division
2011-05-30 2011-05-30 2011-05-30
2011-05-11 63677 2011-05-09 63679 2011-04-18 63258
Type III Type III Type II
N/A N32AE A) N/A B) N/A C) N/A D) N/A E) N/A
A complaint that product set faster than specified on directions for use was confirmed in retained samples and returned product. One complaint indicating syringes for A3 shade of Build-it FR were packaged in outer boxes as A2. The syringes contain the correct shade of A3. It has been determined that the wipes in the kits subject to this correction were made in the same facility as other wipe products, including wipes, swabs and swab sticks, that are the subject of other voluntary recalls due to a potential bacterial contamination issue.
A) Cobas Integra Lipase Colorimetric B) Lipase Colormetric for Cobas BacT/Alert - FA Reagent Bottle A) EOS System B) sterEOS Workstation
Roche Diagnostics GMBH Biomerieux, Inc. EOS Imaging
2011-05-30 2011-05-30 2011-05-30
2011-05-02 63295 2011-04-15 62902 2011-04-13 62903
A) N/A B) N/A 259791 A) EOS B) sterEOS Workstation
Refa8
TMS International BV
2011-05-30
2011-04-04 63158
Type II
0108YYNNNN
108070011
Uri-Drain Male External Catheter with Skin Prep Large Duo-Decapolar Electrophysiology Catheter
Covidien LLC
2011-05-30
2011-04-29 63330
Type II
8884732598
020272164, 100370664
Biosense Webster Inc.
2011-05-30
2011-05-10 63712
Type III
D728260RT
15282044M
A) Paradym DR ICD B) Paradym VR ICD
Sorin CRM S.R.L.
2011-05-30
2011-05-06 63721
Type III
A) 8550 B) 8250
A) STAT 2 Pumpette Primary Set B) STAT 2 Pumpette Extension Set
Conmed Corporation
2011-05-30
2011-04-26 63108
Type II
A) P-S2V-60, P-S2V-60 N B) P-S2-12, P-S2-12 N
A) 0603241-0811031, 0603241-1006094 B) 0603241-1101064, 0603241-1103114
NucliSENS EasyQ Enterovirus
Biomerieux BV
2011-05-30
2011-05-04 63389
Type III
200288
09102001
NovaFlex Delivery System
2011-05-30
2011-05-04 63778
Type I
9350FS23, 9350FS26
Reduction of the I-index claim on the Cobas C Systems from 60mg/dl to 50mg/dl following the increase of concentration of a non-reactive stabilizer in the Lipase R2. Internal investigations have shown that the charcoal suspension density in the FA reagent bottle does not meet specifications. EOS Imaging has discovered that "print true size" print requests from the EOS Acquisition station or the sterEOS Image station may be affected by a different enlargement factor during printing. Therefore, measurements taken manually could be incorrect if the dimensions are not converted according to the scale used on the printed image. The use of a defective Refa8 amplifier in combination with an accessory that would also be defective may pose a safety hazard that is only present in the case of invasive measurements. Covidien is conducting a recall regarding specific lots of Uri-Drain Male External Catheter which include a Smith and Nephew Brand Skin-Prep Protective Wipe. The impacted skin protective wipes may be contaminated with bacteria. Biosense Webster Inc. recently became aware that the Duo-Decapolar Electrophysiology Catheter shipped to customers did not contain the correct instructions for use (IFU). This issue only affects the IFU for the device and not the catheter itself. It was discovered that the bills of materials for the packaging of the Paradym DR and VR ICD models manufactured by Sorin CRM S.R.L. for Canada included a reference to an incorrect patient booklet, the ICD/CRT patient booklet ref O263, instead of the correct booklet, the ICD patient booklet ref N582. Complaints have been received of some devices exhibiting inaccurate flow rates and leakage. If the device is unable to regulate flow as set and confirmed by the attending medical staff and the delivery of essential medications or treatment is dependent on the device's function, this may result in possible injury to the patient. Analytical studies showed that the NucliSENS EasyQ Enterovirus Kit can not detect enterovirus serotype 68 and rhinovirus serotype 87. Therefore, Biomerieux revised the instruction for use of NucliSENS EasyQ Enterovirus products in order to remove these serotypes from the list of the serotypes detected by the kit. An inability to articulate the NovaFlex Delivery System may lead to procedural complications including vessel perforation and potentially patient death. Due to a change in manufacturing processes instituted at Edwards in August 2010, there are reasonable grounds that all NovaFlex units manufactured after this date will function as intended. Although it is believed the likelihood that other units have been impacted is very low, Edwards is recalling all NovaFlex Delivery Systems manufactured before August 2010 in order to eliminate this risk. Affected lots of Solution packs were produced with a wrong conductivity value encoded into the chip. This causes a minor negative bias for the HCT (hematocrite) measurement of 1 to 2% and following failure of the air detection system. A patient who was on a TotalCare bed was medicated for a weight of 53kg when in fact the actual weight of the patient was 73kg. The patient expired the next day and it is inconclusive as to whether the scale was the contributing factor. Cardinal Custom Packs contain the Ethicon Blake silicone drain, connector or J-vac reservoir which are under recall due to the potential for the sterile barrier of the product packaging to be compromised. Gambro has become aware of a possible defect on three lots of the Gambro Accessory S660-C. The defect is a small hole at the level of the female luer connector that could potentially result in an intake of air into the bloodline. The air could subsequently reach the patient without passing through the "air blood" protective system of the dialysis machine. The small hole is not visible to the naked eye. Two U.S. distributed lots of the Advia Centaur, Centaur XP, and Centaur CP EHIV reagents are exhibiting instability. This instability results in the positive control 3 (type O low control) recovering low and out of specification. Reagent lots distributed outside the U.S. have not demonstrated this instability, however as a precautionary measure, the shelf life is being reduced. There is a potential for certain units to fail causing a potential back-flow, and/or free flow condition which could result in over-infusion during use. The fixing strap of the laser aiming devices may inadvertently be detached and land on a patient. The devices were stolen while en route to sterilization facility sometime between April 8, 2011 and April 11, 2011.
Solution packs to ABL80 Basic/Flex Updated recall # 63213 previously posted on 2011-05-16. A) TotalCare Bariatric Bed B) TotalCare P1900 with Scale Custom Sterile Breast Packs
Radiometer Medical APS
2011-05-30
2011-04-18 63213
Type III
944-174, 944-309*
Hill-Rom, Inc.
2011-06-13
2011-01-26 59538
Type II
A) N/A B) P1900 SBA30MAVWA
62718, 62784, 62871, 63038, 63134, 63390, 63480, 63620, 63718, 63864, 62785* A) J079AM6657 to J163AM8107 B) J079AM6657 to J163AM8107 954658, 966888, 971890, 990054
Cardinal Health
2011-06-13
2011-04-12 63022
Type II
Gambro Accessory S-660-C (Hemodialysis Y Connector)
Gambro Dasco S.P.A.
2011-06-13
2011-04-26 63171
Type II
101354-6431233
1035, 1036, 1037
Advia Centaur HIV 1/O/2 Enhanced (EHIV) Assay
2011-06-13
2011-04-29 63251
Type III
01463908
Sigma Spectrum Infusion Pumps A) BV Pulsera Mobile C-Arm System-9 inch. and 12 inch versions B) BV Endura Mobile C-Arm System A) Resolution Clip B) Pinnacle Pelvic Floor Repair Kit C) Advantage Mid-Urethral Sling System D) Advantage Fit System E) Accumax 365 Single-Use Holmium Laser Blood Parameter Monitoring System 101
Sigma International, General Medical Apparatus Philips Medical Systems Nederland B.V.
2011-06-13 2011-06-13
2011-04-07 63259 2011-04-29 63279
Type I Type II
35700 A) 718095 B) 718074 A) M00522610, M00522611, M00522612 B) M0068317050 C) M0068502000, M006850200051 D) M0068502111 E) M0068404020 101
>10 Numbers, Contact Manufacturer A) N/A B) N/A A) ML000019C2 B) ML00000034 C) M0068502000, M006850200051 D) M0068502111 E) M0068404020 1000 to 5556
Boston Scientific Corporation
2011-06-13
2011-05-03 63444
Type II
Terumo Cardiovascular Systems Corporation
2011-06-13
2011-05-09 63652
Type II
Potential for electromagnetic interference (EMI) to affect the accuracy of the values displayed by the CDI 101 system .
A) SERVO-s Ventilator System B) SERVO-i Ventilator System
Maquet Critical Care AB
2011-06-13
2011-05-12 63674
Type II
A) 6640440 B) 6487800
There have been 4 reported instances (not in Canada) where SERVO-i ventilators have malfunctioned when being used during high dose radio therapy by Linear Accelerator (Linac). They stopped working, generated different error codes, reset and started again. No permanent damage or harm to the patient occurred. We are informing our customers that SERVO-i and SERVO-s ventilators are not to be used during high dose radiotherapy by Linear Accelerator (Linac). The manufacturer has never claimed that these devices could be used in this type of environment. Some lots of IdentiCult Albicans Test Kits were incorrectly shipped. Shipping requirements for this product include ice packs to be added to the shipping carton. Affected lot numbers were shipped incorrectly without ice packs which could potentially lead to incorrect results if the product has degraded during shipping. Ortho Clinical Diagnostics (OCD) was notified by a proficiency testing agency that results using VITROS Chemistry Products VALP Reagent were negatively biassed compared to other manufacturers. OCD performed an internal investigation and confirmed that patient results are also affected by this issue. As a result, OCD will be adjusting the calibrator values for VITROS VALP Reagent. Two complaints regarding labelling of RealSeal .04 Taper Point #20 with additional label ML. Actual contents are not RealSeal .04 Taper Points. Correct Plus Putty, dental impression material, does not set within the established specifications. Short Adhesive Removing Replacement Carbide Tips, part # 803-0675 (Lot 09J9J) were mispackaged. Instead they contain Long Adhesive Removing Replacement Carbide Tip, part # 803-0975. Sealed bags of Bond-1 SF 50-pack were shipped without box packaging and kit components. Customer reports were received for breakthrough growth of quality control organisms staphylococcus aureus ATCC 29213 and false positive patient samples. Large roller pump tube clamp mechanism may fail to function, making it difficult to remove or insert the tubing. The version 11 software is unable to detect a catheter fault that occurs due to either an intermittent resistive connection or a thermocouple short proximal to an electrode. When this fault is not effectively detected, the displayed temperature will be lower than the actual tissue temperature. If the actual tissue temperature becomes excessive it may result in coagulum and/or char formation during an ablation procedure. Formation of coagulum/char is considered a hazardous situation which could lead to patient harm (thrombo-embolic complications). The implementation error of the change order for new software in production, 10 Symphony instruments serial number 390051-390060 were manufactured and distributed with software V1.3.2 installed with a V1.3.1 dual air safety valve configuration rather than the V1.3.2 single air safety valve configuration. Reports received of intermittent loss of audio at Intellivue Information Centers, where Philips-supplied PAS-210 Remote Active Speakers Kit were in use. There are two problems that can lead OT intermittent loss. 1) Using a non-Philips supplied audio cable with the PAS210 Remote Active Speaker Kit can prevent proper positioning of the cable and cable retention bracket. 2) When the audio cable supplied with the PAS-210 Remote Active Speaker Kit is used, possible intermittent cable connection can occur causing loss of audio. Malfunction reported of the Air Bubble Detector (ABD) System or the OM. A faulty component on the module's application board was found which can cause the ABD System or Occluder to fail. With the introduction of a replacement mold inconsistency was noted between molds. The previous mold was not producing parts in accordance with the released component drawing and use of new valve block mold resulted in a lower average activation pressure. With the introduction of a replacement mold inconsistency was noted between molds. The previous mold was not producing parts in accordance with the released component drawing and use of new valve block mold resulted in a lower average activation pressure. International Technidyne Corporation has determined that certain lots of HEMOCHRON Jr. Prothrombin Time Cuvettes demonstrate a higher bias than historically observed when compared to laboratory reference instruments. While the lots in question were within specification and met quality control release criteria, a shift in bias occurred that was coincident with a change in a lot of raw material used in the reagent formulation. One complaint that Cement-It Dental Cement set faster than listed in directions for use and in release specifications. St. Jude Medical (SJM) has identified the potential for the failure of the generator and remote control to properly respond to key presses resulting in unexpected energy delivery or the inability to discontinue energy delivery with the start/stop button. The buttons on the console and/or remote may malfunction when the indiff connector or the remote control connector on the console of an impacted generator receives an electrostatic discharge (ESD). A reassignment of the ranges for HDL cholesterol in the materials is necessary. The Peloris II Tissue Processor potentially has a faulty impellor. This potential nonconformance has the capability to lead to reagent carry-over from one processing step to another. The non-conforming impellors have a faulty seal, which could result in reagent seeping into and out of the impellor cavity during tissue processing. The total volume of reagent that could seep uncontrollably in and out of the impellor cavity is less than 1ml.
IdentiCult Albicans Test Kit
Biomerieux, Inc. Portland
2011-06-13
2011-05-09 63731
Type II
302338
513391-1, 516815-1, 518661-1, 520320-1, 522999-1, 524231-1, 525260-1
VITROS Chemistry Products VALP Reagent
Ortho-Clinical Diagnostics Inc.
2011-06-13
2011-05-12 63799
Type III
6801710
1511-14-1230, 1511-14-9776, 1511-14-9894, 1511-14-1094, 1511-14-9637
RealSeal .04 Taper Points Correct Plus Putty Short Adhesive Removing Replacement Carbide Tip
Ormco Corporation, Also trading as Sybronendo Kerr Corporation, Also trading as Pentron Clinical Ormco Corporation Also trading as Sybron Implant Solutions Pentron Clinical Technologies, LLC Becton Dickinson and Company Termo Cardiovascular Systems Corp.
2011-06-13 2011-06-13 2011-06-13
2011-05-11 63846 2011-05-13 63856 2011-05-13 63866
972-2420 Q34H 803-0675, A
126908 179966, 198019 09J9J
Bond-1 SF BD BBL Oxacillin Screen AGAR A) Advanced Perfusion System 1 Base Unit B) Advanced Perfusion System 1 Roller Pump GENius Multi-Channel RF Ablation Generator
2011-06-13 2011-06-13 2011-06-13
2011-05-12 63868 2011-04-21 63246 2011-04-29 63278
N03M 221952 A) 801763 B) 801041, 816571 990018
3598581 1034119 A) 0011-1438 B) 4080-6689, >10 Numbers, Contact Manufacturer 2010004165, 2011003251, 2010004164, 2010145144, 2010145134, 2010004105, 2010004137, 2010145145, 2010145147, 2011003252
Medtronic Ablation Frontiers LLC
2011-06-13
2011-05-05 63535
Type II
Symphony Automated Staining System
Ventana Medical Systems Inc.
2011-06-13
2011-02-11 63847
Type III
N/A
390051-390060
PAS-210 Remote Active Speakers Kit
2011-06-13
2011-05-04 63448
Type II
M3150A, M3151A, M3151B, M3150, M3154
N/A
Air Bubble Detector Module and Occluder
Terumo Cardiovascular Systems Corp.
2011-06-13
2011-03-11 63248
Type II
802110, 803480
01417, 01653, 01721, 01724, 00706, 00874,
Acticon Artifical Bowel Sphincter Control Pump
American Medical Systems Inc.
2011-06-13
2011-05-13 63785
Type II
72402287
35821004 - 690865010
A) Sphincter 800 - Control Pump B) AMS 800 Urinary Prosthesis Control Pump HEMOCHRON Jr. Prothrombin Time Cuvettes
American Medical Systems Inc.
2011-06-13
2011-05-10 63938
Type II
A) 72400098 B) 72404127 J201
A) 331544001-708953020 B) 517943001-707608020 M0JPT095, A1JPT002, A1JPT017, H0JPT078
International Technidyne Corp.
2011-06-13
2011-05-10 63904
Type II
Cement-It Dental Cement A) 1500T14 Cardiac Ablation System-Generator B) 1500T14 Cardiac Ablation System-Remote Control
Pentron Clinical Technologies, LLC Irvine Biomedical, Inc. A St. Jude Medical Company
2011-06-13 2011-06-13
2011-05-09 63843 2011-05-09 63649
Type III Type II
N33, N33A A) IBI-89017 (89017) (1500T1) B) IBI-89018 (89018)
186665, 186676 A) N/A B) N/A
Cholestech LDX Analyzer Leica Peloris Rapid Tissue Processor
Biosite Incorporated Leica Biosystems Melbourne Pty Ltd.
2011-06-13 2011-06-13
2010-10-06 60941 2011-04-10 63137
Type II Type II
10-983 26.0005
SC0146 0265062B
Lite Wand II (Halogen)
Thompson Surgical Instruments, Inc.
2011-06-13
2011-05-03 63453
Type II
400012
N/A
These Lite Wands were originally classified as class I, however upon further discussion, it was determined that this device could be exposed to fat and blood and is therefore considered invasive and should therefore be class II, per rule 1(1) subject to subrules (2) and (3), all surgically invasive devices are classified as class II. Ostase Calibrator and QC vials have been observed to have an increased rate of breakage when stored at -70C and thawed prior to kitting and shipment to the customer. The cracked calibrator and QC vials break and leak reagent in the kit box during shipment to customers.
Access Ostase Calibrators and Access Ostase QC
2011-06-13
2011-05-09 63804
Type II
37305
Access Immunoassay System - PAPP-A (Pregnancy Associated Plasma Protein) Assay
2011-06-13
2011-05-09 63808
Type II
A48571
013968, 014411, 015795, 017948, 830320, 914085, 919454
Beckman Coulter Inc. identified the following issue with the above listed product: 1.Access PAPP-A may exhibit increased imprecision for samples tested from the first two replicates of a reagent pack as compared to the remaining replicates. 2. This issue is only observed on the Access platform, including Access 2, Synchron LXI 725, and UniCel DxC 600i. 3. UniCel DxI platforms are not impacted, including UniCel DxI 600, UniCel DxI 800, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i. The probe wash collar tubing of the sample aspiration module (SAM) may become stretched or trapped during routine use of single-tube presentation station. When the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with respect to the aspirate probe. The misalignment may result in incorrect seating of the probe wash collar and incomplete fluid collection during cleaning. Excess fluid may be dripped across internal surfaces. The product identifier on the retail box packaging (371580) is the wrong number and does not match the (correct) product identifier on the individual case packaging (371500). Beckman Coulter Inc. identified the following issues with the above listed products: issue 1: After downloading interlaboratory quality assurance program (IQAP) files to removable media, the system prevents access to system setup screen and history logs. Issue 2: The online help (IFU) instructions for LH 750 and LH 780 instruments do not provide the correct procedures to format a disk (CD) for saving or archiving data where those instruments are connected to small form factor (SFF) computers. Capsule Neuron UMPC experiences three failure modes that may prevent the parent device from operating according to specifications: (1) Data cached due to server unavailability is not delivered to the server after server availability is restored. (2) Compact flash failure may cause the file system to be corrupted resulting in system hangs, lock-ups or crashes. (3) Batteries can discharge completely even though the device is connected to power.
UniCel DxH 800 Coulter Cellular Analysis System
2011-06-13
2011-05-09 63812
Type II
629029
All lots
Normlgel (15 Gram) A) Coulter LH 780 Hematology Analyzer B) Coulter LH 750 Hematology Analyzer C) Coulter LH 500 Hematology Analyzer
Molnlycke Health Care AB Beckman Coulter, Inc.
2011-06-13 2011-06-13
2011-05-16 63909 2011-05-16 63911
Type III Type II
371500 A) 723585 B) 6605632 C) 178833
10I29-156-41665 A) All lots B) All lots C) All lots
Capsule Neuron UMPC
Capsule Technologie
2011-06-13
2011-03-23 63995
Type II
DC-NU-UMPC
N/A
Ventilateur Legendair - Unite Principale A) 1.0T Signa Horizon Magnetic Resonance B) 1.5 Signa Horizon Magnetic Resonance C) 1.5T Signa Horizon LX Magnetic Resonance D) Signa 1.5T Excite HD - Magnet E) 3.0T Signa HDX MR Sysem - Main Unit F) 1.5T Signa HDX MR System - Main Unit G) Discovery MR750 MR System - Magnet H) 1.5T Signa Infinity Twinspeed with Excite I) Signa 3T MR System - Parts for Main Unit J) Signa Excite 3.0T G3 Magnet K) Signa 1.5T MR System - Main Unit L) Discovery MR450 1.5T MR System - Main Unit M) Signa HDT 1.5T MRI System - 16 Channel Immulite 2500 CMV IGG Pinnacle Pelvic Floor Repair Kit
Airox S.A. GE Medical Systems LLC
2011-06-13 2011-06-13
2011-05-17 63996 2010-11-10 57849
Type I Type II
4095700, 4095705, 4095905 A) M1800MA B) M1000MA C) M1000RA/RD/RF/RG D) M1060LG E) M3335JK F) M3335J, M3335JA, M3335JG G) M7000MA, M7000MC H) M3000TD I) M1060YW J) M3333TD K) SIGNA HDXT 1.5T MR SYSTEM L) DISCOVERY MR450 1.5T MR S M) S7504HP REF L5KCVG2 M0068317050
>100 Numbers, Contact Manufacturer - Covidien Covidien informs of a potential failure of audible backup alarms in the event of power loss to the Ventilator Legendair. A) All Serial Numbers B) All Serial Numbers C) All Serial Numbers D) All Serial Numbers E) All Serial Numbers F) All Serial Numbers G) All Serial Numbers H) All Serial Numbers I) All Serial Numbers J) All Serial Numbers K) All Serial Numbers L) All Serial Numbers M) All Serial Numbers SMN 13081220 1ML0070801 If gradient cables are inadvertently swapped while servicing and geometry check not performed as required in procedure, images may be flipped left-right with incorrect orientation annotation.
Siemens Healthcare Diagnostics Products Limited Boston Scientific Corporation
2011-06-13 2011-06-13
2011-04-28 63220 2011-05-11 63913
Type II Type II
The Immulite 2500 CMV IGG assay does not have Health Canada licensing approval. A portion of units may exhibit low tensile strength between the needle and the suture, which could potentially lead to needle detachment during mesh leg replacement. If needle detaches during placement, user may elect to leave the needle in body or try to locate needle and attempt to retrieve it. Philips received a complaint that the patient table collapsed in the vertical direction with a patient on the table. Philips has determined that the root cause was a failure with the vertical brake hub of the patient support.
A) Brilliance 40/64 Slice CT System B) Brilliance CT Big Bore System-Main Unit C) Brilliance 64 Slice CT System-Main Unit D) Brilliance ICT System-System E) Brilliance 6/10/16 Slice CT System F) Brilliance CT System (16P) Spacelabs Medical Capnography Module
2011-06-13
2011-05-20 63918
Type II
A) 4550 11004011 B) 4535 670 88051 C) 4550 110 00921 D) 728306 E) 4535 670 73181, 4535 670 78851 F) 453567005721 91517
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A >100 Numbers, Contact Manufacturer
Spacelabs Medical, Inc.
2011-06-13
2011-05-16 63922
Type II
A) Hitachi Creatinine Kinase-MB Liquid (CK-MB) B) Hitachi Creatine Kinase Liquid, Acc. to IFCC (CK) C) CK (Creatine Kinase) for Cobas C701 Analyzer PleuraFlow Catheter System External Nasal Splint Kit
2011-06-13
2011-05-13 63928
Type III
Clear Catheter Systems Invotec International Inc.
2011-06-13 2011-06-13
2011-04-19 63930 2011-05-20 63933
Type III Type II
A) 12132834216, 12132893216 B) 04580591190, 04580613190, 12132524216, 12132672216 C) 05168546190 PF-20, PF-32 20-10101
A) All lots B) All lots C) All lots 7844-05, 7844-06 29810
Advantage Workstation Thoracic VCAR
GE Medical Systems SCS
2011-06-13
2011-05-06 63538
Type II
5339892-X
N/A
Spacelabs Healthcare discovered during internal testing that the capnography module resets 20 seconds after power failure, instead of after 3 minutes as specified. This reset clears the ram and the module returns to default settings. The manufacturer implemented a new master application for the reagents that would require a change in the measuring range of the methodologies as documented in the respective package insert and instrument configuration parameters. Removal of product from distribution that exhibits possible vacuum/suction leaks. The leak is attributed to incomplete bond between the chest barb connection and the guide tube. The Nasal Splint Kit contains a "skin-prep protective wipe". This wipe is subject to a recall by the manufacturer "The Triad Group/H&P Industries" due to potential bacterial contamination with Bacillus cereus. When using the summary table feature on Thoracic VCAR to display data, incorrect patient name will be displayed if the user does not exit the application in between the analysis of two consecutive patients. If the user did not exit the application, the correct imaging study will appear and the data on the summary table will contain the results of the current patient imaging study, however, the previous patient name will be displayed on the summary table. This summary result may be separated from the remainder of the CT imaging exam if it is printed on film or paper and incorrectly inserted in another patient's file. This issue may cause confusion and possible incorrect assessment. No adverse event has been reported related to this issue. Individuals attempting to remove a lancet from the OneTouch Delica Lancing Device without following the instructions for use may experience an accidental needle stick. In addition, over tightening of the cap may cause the needle to be exposed after firing, which could also result in an accidental needle stick.
OneTouch Delica Lancing Device
LifeScan Europe, A Division of Cilag G.m.b.H. International
2011-06-13
2011-05-23 64104
Type II
012-839
A-58277
A) Synchron LX20 System Analyzer - Class 2 B) Synchron LXI 725 C) Synchron LX20 PRO
2011-06-27
2011-04-04 62792
Type II
A) 466002 B) 476501 C) 476100
A) All lots B) All lots C) All lots
Beckman Coulter Inc. has confirmed the following maintenance-related hardware issues can cause or contribute to erroneous electrolyte results on the Synchron LXR20, Synchron LXR20 PRO and Synchron LXRI 725 clinical systems: 1. Ratio pump wear, 2. Silver iodide build-up on the chloride electrode, which if not removed may affect chloride performance and shorten the usable life of the electrode, and 3. Microbial contamination introduced into the system via the deionized water source, reagent straws, or other external sources. The use of incompatible bleach and saline products for the twice-weekly flow cell cleaning procedure may introduce electrolyte instability in the Synchron LX20 system. IV Prep Antiseptic Wipes are packaged inside the "Site Adhesive Sample Kit". These wipes are part of a recall by the distributor "Smith & Nephew" due to a potential bacterial contamination found at the manufacturer "The Triad Group". (Lot# for "IV Prep Antiseptic Wipes": 9K141, 9K142, 9K143, 0F131, 0F140, 0G249, 0G255, 0G256, 0G259, 0K139, 0K140, 0K193, 0M180, 0M216, 1A212, 1A213). Centricity Laboratry instrument interface to data innovations (DI) is processing a preliminary result instead of the final result from the process manager (PSM). When PSM reruns (repeats) a test, the PSM sends both preliminary and final results in the same result message, but only the preliminary result is filed and reported. During a review of records at the Buffalo Grove Global Technical Services Center in the U.S., it was determined that a service technician may have failed to perform the dielectric voltage withstand (HIPOT) test on Colleague Infusion Pumps that were serviced between April 1, 2008 and November 14, 2008. User update, a voluntary safety alert to preventatively address inadequate cooling reports and educate customers on the possibility of damage to the MPS or MPS2 Console under these use conditions. In the manual exposure mode, if the exposure switch is pressed at the same time as one of the technique buttons, it is possible that one of the technique parameters (KV, MA, MAS) may continue to ramp up or down, resulting in a higher or lower x-ray dose than intended. An additional exposure may be needed in order to obtain an image of desired quality.
Sample Tape Kit
Medtronic MiniMed
2011-06-27
2011-04-08 62956
Type II
MMT-643
N/A
Centricity Laboratory-Core Lab
GE Healthcare
2011-06-27
2011-05-04 63451
Type II
CORE
N/A
Colleague Volumetric Infusion Pump
2011-06-27
2011-05-06 64128
Type II
2M8161
15084164CC, 15102333CC
A) MPS Myocardial Protection System Console B) MPS2 Console
Quest Medical, Inc.
2011-06-27
2010-08-01 64204
Type III
A) 5001000 B) 5201260
A) Bucky Diagnost B) Trauma Diagnost
Philips Medical Systems DMC GMBH
2011-06-27
2011-05-20 64032
Type II
A) 9890 010 83821 B) N/A
A) N/A B) N/A
CADD-Solis Infusion Pump, Model 2120
2011-06-27
2011-05-24 64115
Type I
21-2120-0100-50
Serial Numbers 1014628 and lower
Smiths Medical has become aware of a small number of complaints for significant underdelivery/non-delivery of fluids when the CADD medication cassette reservoir or administration set is not correctly latched to the pump. Device has lost the ability to communicate or recharge, resulting in loss of pain relief and possible subsequent explant. In the cases reported, the duration between recharges became progressively shorter until the IPG failed to charge or there was a sudden loss of power which resulted in device replacement. When the function "lower table height" is activated by the user and a patient is sitting next to the table and patient's lower extremities are under the table top, the possibility exists that parts of the table may impact the patient's lower extremities. Recall initiated due to a potential of these draining bags to leak during patient use. Important notice: on May 17, 2011 the recall have been expanded to lots # 100283 and # 101792. In Aquilion One System the following software issues have been noted. (1) The confirmation may not be displayed properly during scanoscopy. (2) If the PGP hard split option is used and the scano skip button is pressed, the second scanoscopy may not be completed. (3) The use of PGP hard split may result in an error in image display processing. (4) If more than 10 characters is entered in the image comment, the system software will terminate abnormally. The product hardens faster then what was specified in the instructions. The GEM Premier 3500 System has identified that the patient ID from the previous sample was transmitted to the wrong file on their GEM Premier 3500 instrument. This event occurs specifically when they misuse the GEM Premier 3500 barcode gun by repeatedly clicking the gun, which can potentially cause the instrument under certain conditions, to attach the test results to an incorrect patient ID. The reagent Elecsys anti-HAV revealed a signal increase for calibrators/controls and sample patients when the reagent was left onboard the analyzer for more than 3 weeks. A malfunction of the modular reverse diodes (DLA), a component in the equipment of the Elekta Linear Accelerator, which have ruptured. Failures have occurred sometime after beam termination. Discrepancy between some of the flow sets in valves manufactured between January 2009 and October 2010. This flow rate deviation may cause patients to receive a smaller or larger dose of medicinal oxygen. There is an obvious possibility of inadvertently touching the non-protected electrical parts while taking a water sample which can lead to a severe electric chock, potentially causing serious injury. Baxter Corporation is recalling a single lot of the product because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient. Steris has learned through customer feedback that Vision SC Washers are experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit. Affected Oral / Enteral syringes have a trace amount of nickel sulfide.
Eon Mini Neurostimulation System-Implantable Pulse Generator
Advanced Neuromodulation Systems, Inc.
2011-06-27
2011-05-25 64172
Type II
3788
702822, 704723, 710755, 711005
A) Ysio Radiography X-ray System Full Motorized B) Ysio Radiography X-ray System Semi Motorized
Siemens AG
2011-06-27
2011-05-26 64142
Type II
A) 10281013 B) 10281163
A) >10 Numbers, Contact Manufacturer B) 30010, 30064, 30068, 30069, 31039, 31083
Remington Medical 600-D Drainage Bag Updated recall # 61102 previously posted on 2011-02-21.
Remington Medical, Inc.
2011-06-27
2011-01-18 61102
Type III
600-D
083302, 100283, 101792
Aquilion One System - Main Unit
2011-06-27
2011-05-27 64173
Type II
TSX-301A/2
A) Cement-It - Cementation System Kit B) Cement-It-Automix Syringes, Catalyst & Base GEM Premier 3500 System
Pentron Clinical Technologies, LLC Instrumentation Laboratory Company
2011-06-27 2011-06-27
2011-05-20 64219 2011-04-01 64262
Type III Type II
A) N33 B) N33A 00026000000
A) 186665 B) 186676 >10 Numbers, Contact Manufacturer
Anti-HAV Kit A) Elekta Precise Treatment System B) Elekta Synergy Platform C) Elekta Infinity M706
Roche Diagnostics GMBH Elekta Limited
2011-06-27 2011-06-27
2011-05-27 64018 2011-05-06 64096
Type III Type II
04854977190 A) MRT 6001, MRT 6011 B) XRT 0401, XRT 0411 C) XRT 1501, XRT 1511 N/A
16065601 A) 105627, 105785, 151311, 105821, 105871, 105706, 151578 B) >10 Numbers, Contact Manufacturer C) 152094, 151939, 151940, 151941 M70600154
Ceodeux S.A.- Meditec
2011-06-27
2011-05-20 64095
Type II
Getinge 8666-8668 Washer Disinfectors
Getinge Disinfection AB
2011-06-27
2011-03-28 64502
Type II
8666, 8668
W50010963
Epidural Solution Administration Set
2011-06-27
2011-06-03 64503
Type II
2C7554S
GR293209
Reliance Vision SC Washer/Disinfector
Steris Canda Corporation
2011-06-27
2011-05-09 63896
Type III
FH05072
All Serial numbers
A) Oral / Enteral Syringe B) Sample Pack Oral / Enteral Syringe
Philips Children's Medical Ventures
2011-06-27
2011-05-06 64039
Type III
A) 1062680, 1062681, 1062682, 1062683 B) 1063224, 1078782
Aquilion 64
2011-06-27
2011-05-27 64174
Type II
TSX-101A/H
HCB1023750, HCB1083820, HCB1083821, HCB10X3839
In the Aquilion System the following software issues have been noted: (1) The confirmation may not be displayed properly during scanoscopy. (2) If the PGP hard split option is used and the scano skip button is pressed, the second scanoscopy may not be completed. (3) The use of PGP hard split may result in an error in image display processing. (4) If more than 10 characters is entered in the image comment, the system software will terminate abnormally. (5) Under certain circumstances if the helical skip button is clicked during one of the scanning, the next helical scan may stop before it is completed. Treatment plans with differing fraction sizes from certain versions of tomotherapy Hi*Art are not recognized as having multiple fraction groups. It is also assumed that curves, calibration depth and output factor depth all have the same offset. In affected lots, recovery in plasma (EDTA, lithium heparin) specimens may exhibit on average, a 36% positive bias (with a 95% confidence interval of 26% to 46%). Serum specimens are recovering as expected. Rare occurrences of falsely lowered K+ results (potential negative bias of 0.6 to 1.2 mmol/l) can occur during cartridge life on patient blood analysis, leading to erroneous results with potentially severe impact to patient treatment. Addition of the Langston Dual-Lumen Pigtail Catheter, model 5515 lot# 548264 to the scope of the previous field action 2134812-08/31/2010-001R as having a missing sterile barrier pouch seal. Zimmer is initiating a recall of certain lots of NexGen Complete Knee Solution (CKS) posterior referencing instruments (PRI) because they have a potential for exhibiting a breakdown of the aluminum/titanium nitride PVD black coating. The NexGen PRI utilize this coating as a cosmetic means to depict points of attachment or adjustment of the instruments.
SharePlan 1.1
RaySearch Laboratories AB
2011-06-27
2011-05-30 64415
Type III
1.0
Software version 1.3.1.10
LIASON 25 OH Vitamin D TOTAL Assay
Diasorin Inc.
2011-06-27
2011-06-13 64628
Type II
310600
GEM Premier 4000 System
Instumentation Laboratory Company
2011-07-11
2011-06-02 64659
Type II
00025000000
06050100 to 11064853
Langston Dual Lumen Pigtail Catheter Model 5515
Vascular Solutions, Inc.
2011-07-11
2011-06-07 64677
Type II
5515
548264
A) NexGen CKS Quick-Connect Handle B) NexGn CKS Posterior Referencing Sizer C) NexGen CKS Postier Referencing Sizer Boom D) NexGen CKS Modular T-Handle E) NexGen CKS Distal Femoral Resection F) NexGen CKS Femoral Valgus Alignment G) NexGen CKS Extramedullary Distal Telescoping H) NexGen CKS Extramedullary Proximal Telescoping I) NexGen CKS Extramedullary Modular Spike J) NexGen CKS Patella Osteotomy Guide K) NexGen CKS Patella Clamp L) NexGen CKS Femoral & Provisional Impactor/Extractor M) NexGen CKS Patella Peg Drill Guide Updated recall # 62538 previously posted on 2011-04-18.
Zimmer Inc.
2011-07-11
2011-03-24 62538
Type II
A) 00590103400 B) 00590104000 C) 00590104010 D) 00590106100 E) 00590106300 F) 00590106700 G) 00590107100 H) 00590107200 I) 00590107400 J) 00590301000 K) 00590302000 L) 00590102600 M) 00590306000
A) 61612789, 61682485, 61550601 B) 61558673, 61610687 C) 61558201 D) 61517185, 61609572 E) 61548704, 61615895 F) 61559529, 61625078 G) 61559187, 61633778, 61678730 H) 61543636 I) 61549223, 61593951 J) 61559367 K) 61555948, 61635432 L) 61522231, 61550613, 61637191, 61657309, 61659596 M) 61511575, 61542246, 61630733
A) Signa HDX MR System B) Discovery MR750 MR System C) Discover MR450 1.5T MR System Vinci 600 System - Reciprocating Saw
2011-07-11
2011-06-10 64154
Type III
A) M3335JA B) M7000BH C) M7000MJ 17306210
A) 1458927, 1469491, 1490961, 1537273 B) 1457924 C) 1496688, 1538397, 1590426 01060, 01251, 01002, 01003, 01004
In the event of a significant power surge, such as one that might be caused by a lightning strike or a utility equipment failure, there is a possibility that the fuse in the MRU (magnet rundown unit) circuit could be affected. This situation could indirectly lead to a potential hazard if an emergency magnet quench is required. Following a complaint concerning the reciprocating saw attachment V600 SR (ref: 17306210), extensive tests have shown that in some cases screws can become loose or might even come off (the attachment). Certain lots of the Versys Advocate Hip System (Femoral Stem Cemented) may contain an incorrect proximal centralizer packaged with the stem. The centralizer packaged with these lots, if attempted to be used, may not mate properly with the stem. B&B Medical has been advised by the supplier of the skin prep pad, Smith & Nephew, that due to manufacturing problems they are recallin g their skin prep products. The pads are provided in each package of B&B Medical E.T. Tape. Smith & Nephew has identified an issue with insufficient weld penetration which joins the shaft tube and blade tip. This may cause the blade tip to separate from the tube shaft during use. During transport of the cart with a docked DCU, a front caster (wheel) may become loose and fall off. If this occurs, the cart will become unbalanced and fall. Zimmer is initiating a recall of certain lots of the Zimmer Contoured Small Blade instrumentation because the instruments within these lots contain a protruding weld that may prevent the blade from sliding onto the corresponding retractor frame as intended. This recall is being performed due to the fact that the product is not licensed by Hologic in Canada. The product is not defective in any way. The content of the PK7300 on-line help file and the PK7300 user's guide are different. Change control is in place for hard copy versions of the user's guide and the local hard copy is the primary reference for the operators. There is no assurance that the on-line version of the user's guide has up to date "instructions for use" in all languages. Nobel Biocare has received complaints regarding an incorrect impession coping. After investigation at Nobel Biocare Karlskoga it was discovered that the wrong label and color coding has been used for one batch of the product impression coping open tray CC. The information stated on the label is: Impression Coping Open Tray CC NP 5 x 14 mm (article no. 36261. Lot 742552). The impression coping included in this package is impression coping open tray cc rp 6 x 14 mm (article no. 36266). During a review and retest of the sterilization parameters, Stryker Endoscopy discovered that the 132OC gravity steam sterilization cycle did not consistently sterilize all of the products in the tray. Speakers on SureSigns patient monitors and vital signs monitors may fail prematurely. This failure may be identified by the display of a "speaker malfunc" message in the alarm message area or an "audio failed" message in the main screen of the device or by the absence of audible sound. Optima MR360 1.5T: in the event of a significant power surge, such as one that might be caused by a lightning strike or a utility equipment failure, there is a possibility that the fuse in the MRU could be affected. This situation could indirectly lead to a potential hazard if an emergency magnet quench is required. ConMed Linvatec has beed advised by a supplier that the power supply in the manufacture of the lS7600 and lS7700 potentially has an unapproved component and may not meet finished product requirements.
W&H Dentalwerk Burmoos GMBH
2011-07-11
2011-05-31 64424
Type II
A) Versys Advocate Hip System, Femoral Stem B) Versys Advocate Hip System, Femoral Stem, Extended Offset A) StabilTube B) E.T. Tape C) E.T. Tape II
Zimmer Inc.
2011-07-11
2011-06-13 64816
Type II
A) 00-7850-017-00 B) 00-7850-016-20
A) 60457914 B) 60530789
B&B Medical Technologies
2011-07-11
2011-04-14 63192
Type II
A) BB11060 B) BB11020 C) BB11010 A) 7205341 B) 7205336
A) D024411, D029817 B) D025715 C) D033320, D036402, D102427 A) 50561144 B) 50540107
A) Dyonics Power Shaver Blade-Full Radius Smith & Nephew, Inc., Endoscopy Division B) Dyonics Power Shaver Blade-Full Radius, Curved, Convex
2011-07-11
2011-05-12 63814
Type II
Expression MRI Patient Montoring System-Main Unit Zimmer Contoured Small Blade
Invivo Corporation Zimmer Inc.
2011-07-11 2011-07-11
2011-06-03 64640 2011-06-14 64817
Type II Type III
865214 00-7804-001-06
N/A 61494028, 61669212
A) Biopsy Site Identification Markers B) Hologic Breast Biopsy Kit
Hologic, Inc.
2011-07-11
2011-04-11 63830
Type II
A) PK7300 Automated Microplate System - Instrument Class 3 Beckman Coulter, Inc. B) Beckman Coulter PK7300 Automated Microplate System (Donor Screening) - Instrument
2011-07-11
2011-06-02 64395
Type III
A) CELEROMARK, TRIMARKTD-2S-13-12, TRIMARKTD-2S-13MR, TRIMARKTD2S-36-09 B) MME-00345 A) PK7300 B) PK7300
A) All lots B) All lots A) All lots B) All lots
Impression Coping Open Tray CC NP 5 x 14mm
Nobel Biocare AB
2011-07-11
2011-05-05 64562
Type III
36261
742552
Instruction for use for 45cm Laparoscopic Instruments Sterilization Trays SureSigns VS3
Stryker Endoscopy
2011-07-11
2011-06-09 64651
Type II
0250-015-704
All lots
2011-07-11
2011-06-10 64855
Type II
863069, 863071, 863073, 863074
N/A
Optima MR360 1.5T
GE Hangwei Medical Systems Co. Ltd.
2011-07-11
2011-06-10 64935
Type III
5312366 (M50002BB)
1591211
Xenon Universal Light Source
Linvatec Corporation D.B.A. ConMed Linvatec
2011-07-11
2011-05-20 63916
Type III
LS7700
72605
EZ-OX Plus Oxygen Regulator
Vitalaire Canada Inc.
2011-07-11
2011-05-20 64020
Type II
ALQ-2342
N/A
Cook Sydney IVF Hyaluronidase Kits Coherence Therapist
William A. Cook Australia, PTY. Ltd. Siemens AG
2011-07-11 2011-07-11
2011-05-31 64304 2011-05-26 64362
Type III Type III
K-SIHY-1-5 8147667
Impax for Cardiology - Clinical Review Station Impax Cardiovascular (CV) Admin Tool
AGFA Healthcare N.V. AGFA Healthcare N.V.
2011-07-11 2011-07-11
2011-06-08 64646 2011-06-08 64647
Type II Type II
60+00007791 60+00007791
One customer reported sudden and rapid emptying of an oxygen cylinder with the EZ-OX Plus Oxygen Regulator. This was detected by the audibly loud noise of a pressurized cylinder emptying rapidly. A877629, A877483 Two lot numbers recalled in Canada due to the receipt of information that hyaluronidase material of incorrect origin was used in the manufacture of the device. 10013, 10018, 071206-WI, P011206_R1, 11060 Sites with at least Primeview (R2.1 or 2.2) and RTT 4.1 connected to the same Lantis DB (version 6.1 and 8.3) may observe concurrent DB access issues. In this case Primeview displays an error message that informs the user about potential recording failures. A segment recording failure with data loss might be the consequence. RM 2.04.37.04 to RM 7.8 SU2 When using the Impax CV reporting (RM) module, PDF renderings of final reports may be inaccessible if a merge was performed on a previously signed report. Software Versions 1.00.26, 1.00.27, CV7.4.SU3, CV7.8 end-user requests to move a report into a study that currently has a report associated If the with it, the system will allow the move, however the result is that there is no indication that the moved report exists when viewing the study through the user interface. DICOMStore 2.04.44 and earlier AGFA initially identified the need for CRS upgrades when a customer in Canada, Edmonton Cardiology Consultants, performed echocardiography volume measurements within CRS that were not reflected correctly in associated results management (RM) reports. connexes. One part of the instrument was made with wrong raw material, common steel instead of stainless steel. A mistake by the raw material supplier that sent to Medacta's supplier, a certificate for the stainless steel but with the wrong material. The supplier did not notice the mistake and manufactured the entire lot. The wrong material was discovered to be used. Sites with at least Primeview (R2.1 or 2.2) and RTT 4.1 connected to the same Lantis DB (version 6.1 and 8.3) may observe concurrent DB access issues. In this case Primeview displays an error message that informs the user about potential recording failures. A segment recording failure with data loss might be the consequence. There is a potential safety risk when delivering beams without imaging segments for which a manual pause for the imaging segment is set. As a consequence of this risk the patient may be injured or mistreated. There is incorrect activity levels stated on the instructions for use labeling in the Leukosure Enumeration Kit due to the inaccurate activity values provided by the supplier for the raw material ribo-nuclease a type III-A, utilized as a component of the Leukosure Stain Reagent. The activity value for these lots is 3.25ku/ml, as compared to 4ku/ml as stated in the product labeling. Alteration of the staining enumeration of white blood cells (WBC) in blood component preparation might produce falsely high values of white blood cells in samples with high levels of residual RNA. These high values may result in the the blood component being considered inappropriate for use in transfusions, thereby reducing the availability of blood for transfusion procedures. The high values may also result in unnecessary reprocessing of the blood component. Beckman Coulter Inc. identified the following issue with the above listed products: 1. The dilution recovery (linearity) data presented in the Access Testosterone instructions for use (IFU) does not represent the current product performance. 2. In a recent study, thirty-four (34) male serum samples with testosterone values from 4 to 10ng/ml were diluted 1/2 in Access Testosterone Calibrator S0. The neat and diluted samples were then measured using the Access Testosterone Assay. The calculated mean recover was 110% (range = 95 to 137%). There is a gap between the stationary portion of the table and the extendable patient pallet. When the pallet is being translated patients' body parts (e.g. hair, skin, or fingers) or items (such as clothes and IV tubing) may get caught between the stationary portion of the table and extendable patient pallet if the instructions for use are not followed. Sensitivity failures on BD FACS 7 Color Setup Beads, causing failure on the BD Facscanto or Facscanto II Systems BD FACS 7 Colour Setup report. The assortment packs of ProTaper Universal Gutta Percha points, item# PTUGPAST with lot# 110381, may have the size F1 in the F5 slot and the size F5 in the F1 slot. Safety issue fix for VB10, VB10A, VB10B, VB10C systems. Meaurement results from a previous study containing a patient report may be merged to the next patient study. The Avitene instructions for use (IFU) have been revised to include a warning or precaution on the possible development of post-operative inflammatory reaction to the device, including its clinical features and its timing.
Impax for Cardiology
AGFA Healthcare N.V.
2011-07-11
2011-06-08 64648
Type II
60+00007791
Versafitcup Double Mobility Liner Inserter
Medacta International SA
2011-07-11
2011-05-24 63981
Type III
01.26.10.0018
105549
Axiom Artistos MX
Siemens AG
2011-07-11
2011-05-31 64399
Type II
5895003
A) Artiste MV - Linear Accelerator - Syngo RT Therapist Assisit Siemens AG B) Artiste MV - Linear Accelerator - Syngo RT Therapist
2011-07-11
2011-06-03 64565
Type II
A) 08162807 B) 08162815
A) 10024, 10048 B) 10040, 10003
Leukosure Enumeration Kit
2011-07-11
2011-06-01 64567
Type II
175621
5621012K, 5621013K, 5621014K
Access Testosterone Reagent Pack and Calibrator
2011-07-11
2011-05-23 64584
Type III
33560, 33565
All lots
Brightview Gamma Camera System with 3/8" Crystal
2011-07-11
2011-06-17 64897
Type II
2170-3000A
N/A
BD FACS 7-Color Setup Beads ProTaper Universal Gutta Percha Acuson S2000 A) Avitene Microfibrillar Collagen, Web B) EndoAvitene Microfibrillar Collagen C) Syrine Avitene Microfibrillar Collagen D) Avitene UltraFoam E) Avitene Microfibrillar Collagen Flour Luminos DRF Updated recall # 63437 previously posted on 2011-05-30.
Becton, Dickinson and Company BD Biosciences Dentsply Tulsa Dental Specialties, Trading as Dentsply Endodontics Siemens Medical Solutions USA, Inc. Davol, Inc., Subsidiary of C.R. Bard Inc.
2011-07-11 2011-07-11 2011-07-11 2011-07-11
2011-05-20 64874 2011-06-15 64898 2011-06-15 64899 2011-06-24 64949
335775 N/A 10041461 A) N/A B) N/A C) N/A D) N/A E) N/A 10094200
83284, 87471, 02073, 02450, 02452, 02453 110381 N/A A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) WBRJFD43 D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer 2001, 1187, 2007, 2060, 2110, 2133
Siemens AG
2011-07-11
2011-04-06 63437
Type II
This update instruction provides multiple bug fixes and system improvements, such as, enhanced direct radiation detection leading to wrong window values, wrong PEX-settings for spatial frequency parameters leading to black images, imaging system crash with cancel of reject analysis window, wrong flags in patient list, improvement of auto delete function, improvement of error 3070/032, and improvement of error 7031/032. Leica Biosystems recently became aware that there is a potential issue with the Bond Oracle HER IHC System TA9145 lot numbers 12135 and 13341. They have become aware of a potential occurrence of over-staining on procedural control cell-lines that are supplied as part of the system. There is the possibility that the over-staining may be observed in inhouse tissue controls and/or patient tissue. The potential exists for data stored within the memory to be duplicated when uploaded to the chromatography data acquisition computer. As a result, a previously reported section of the chromatogram could be repeated. Stryker Medical has determined that some impression covers were manufactured with bottom cover material that did not meet their specifications. As a result, some of the impression mattresses with flame barrier option do not comply with the flame-retardancy requirements, as specified in the code of Federal regulations.
Bond Max System-Usher2 (Oracle HER2 Bond IHC System)
Leica Biosystems Newcastle Ltd.
2011-07-25
2011-05-23 65003
Type III
TA9145
12135, 13341
Ethernet-SATellite INterface (e-SAT/IN) Module
Waters Corporation
2011-07-25
2011-06-13 65036
Type III
668000230
All lots
Impression Matress Cover (Fire Barrier Option)
Stryker Medical
2011-07-25
2011-05-27 64147
Type II
2980-000-000, 2980-000-002, 2980-000-004, 2980-000-006, 2980-000-008
All lots
Vitros Chemistry Products PHBR Slides
2011-07-25
2011-06-27 65138
Type II
8221384
2532-0053-0217, 2532-0053-1490, 2532-00534961, 2532-0053-0149, 2532-0053-4996, 2532-00531488 A) N/A B) N/A
A) Seno Advantage 2.1 Volumeshare 2/4 B) Seno Advantage 2.2 Volumeshare 2/4
2011-07-25
2011-06-21 64537
Type II
A) 5183685-X B) 5342425-X
Ortho-Clinical Diagnostics has received customer complaints of intermittent imprecision, outliers or shifts in control fluid values when using various lots of Vitros Chemistry Products PHBR Slides (phenobarbital) from coating 0053. The investigation confirmed that biased values for patient samples could be obtained that may or may not be detected by quality control fluids. When Seno Advantage Workstation is synchronized with Radiology Information System (RIS) using Clinical Context Object Workgroup (CCOW) (an Hl7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1. Two different patient images may be displayed at the same time. The Seno Advantage Workstation may display one patient's multi-modality images on the 1 megapixel (landscape) color monitor and another patient's mammography images on the 5 megapixel (portrait) high-resolution black and white monitors. The patient name annotation is correct whenever it is displayed on any monitor. 2. The patient images displayed on the Seno Advantage high-resolution black and white monitors may not show images of the patient selected on RIS and on the Seno Advantage color monitor. The patient name annotation is correct whenever it is displayed on any monitor. A false screening risk score can be potentially reported due to patient data overwriting. Plastic seat may not meet measurement specification. In these cases, the seat may not fit the unit properly and may interfere with the unit's normal locking mechanism. There are circumstances in which the seat could unintentionally begin to rise should it fail to lock as intended. Beckman Coulter Inc. has determined through ongoing quality assurance measures that the J6-MI High-Capacity Centrifuge may be susceptible to electrostatic discharge during operation. Stryker has received reports of difficulty in rod rotation using the Mantis Rod Inserter. It was reported that the Mantis Rod Inserter tip could disengage from the shaft. Amplification Kit, lot A02283, has a reagent registration button that contains incorrect expiration dating information. As a result, after scanning the registration button information into instrument, the kit will only provide a useful life through 19-July-2011. The date should have been 27-Dec-2011. The actuator that operates the helmet hoist has a limited life span and may fail. Ge Healthcare has become aware that scan will not complete if Smartprep is used in combination with new GSI presets GSI-31, GSI-32, GSI-33, or GSI-34 on Discovery CT750 HD Systems. The latex reagent component of the test kit fails to cause agglutination in patient samples containing levels greater than 250 ng/ml of D-Dimer. The failure will give a false negative result for the test. Baxter Corporation, the current device licence holder, is providing a follow-up to earlier notices from Edwards Lifesciences, the previous device licence holder, concerning Edwards Aquarius software versions 4.01.11 and 4.01.12, and reports of significant fluid imbalance in patients, related to repeated overriding of the fluid imbalance alarms of the Aquarius system software, contrary to the operating manual of the device. The use of HLA Fusion version 2.0.0-SP1, RSSOH1AC_update.exe with analysis of following kits/products may cause a conversion error giving incorrect test results. There is an anomaly in Eclipse versions 8.0 to 8.6 whereby a particular plan approval workflow may result in a difference between the intended SSD value and the SSD value communicated to the treatment delivery system.
LifeCycle for Prenatal Screening Uplift Commode Assist
Wallac OY Uplift Technologies Inc.
2011-07-25 2011-07-25
2011-06-08 64569 2011-06-27 65162
Type II Type II
5002-0020 CA 200
v3.0 RevX, v3.1 Revv2 1C0101
J6-MI High-Capacity Centrifuge
2011-07-25
2011-06-02 64583
Type III
360291, 360292, 360293
All lots
A) Mantis System - Rod Inserter B) Mantis System - Rod Inserter Inner Shaft Amplification Kit
Stryker Spine SAS Ventana Medical Systems Inc.
2011-07-25 2011-07-25
2011-06-14 64879 2011-05-27 64991
Type II Type III
A) 48284053 B) 48284052 760-080
A) All lots B) All lots A02283
Leksell Gamma Knife C1.2, 4 and 4C Discovery CT750 HD Computed Tomography X-Ray System
Elekta Instruments AB GE Medical Systems, LLC
2011-07-25 2011-07-25
2011-05-26 65089 2011-03-23 65178
Type II Type III
912800 B7877HD
4310 N/A
Minutex D-Dimerkit, Part No. 150707
Tcoag Ireland Limited
2011-07-25
2011-06-02 65192
Type II
150707
C040002, C042002, B218005, B341002, B144001 .0698, .0700, .0757, .0779, .0927, .0940, .0941, .0970, .1467
Aqarius Software V. 4.01.11/4.01.12
Baxter Healthcare SA
2011-07-25
2011-06-29 65217
Type II
GEF08200
HLA Fusion Software, version 2.0.0-SP1, RSSOH1AC_Update.exe A) Eclipse Ocular Proton Planning V1.1 B) Eclipse Smart Segmentation C) RapidArc, also known as Dose Dynamic Arc / Volumetric Modulated Arc Therapy
One Lambda Inc.
2011-07-25
2011-01-17 62661
Type II
N/A
version 2.0.0 SP1, RSSOH1AC
2011-07-25
2011-04-04 63895
Type II
A) TPA001075000 B) TPA001094000 C) UP9001
A)>10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant B) H484530, H484531, H484526, H484527, H484528, H487407 C)>10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant >10 Numbers, Contact Manufacturer
Cypher Select Plus Sirolimus-Eluting
Cordis Europa N.V.
2011-07-25
2011-06-29 65225
Type II
CRB28225, CRB28250, CRB28275, CRB28300, CRB28350, CRB33225, CRB33250, CRB33275, CRB33300, CRB33350
Cordis is informing customers that there is a possibility of having units within the distributed lots of Cypher Select Plus Sirolimus-Eluting Coronary Stent (catalog numbers CRB33XXX and CRB28XXX) that may not meet the Cordis internal design specification for stent expansion uniformity (SEU). The SEU acceptance criterion for Cypher product is less than 10 percent. There is a possibility that certain lot numbers of the 24k100, 24k Arthroscopy Outlfow/Suction Tubing Set may have a breach in the tyvek pouch, thereby potentially compromising the sterility of the device. The current access and DXI instrument manuals specify an unrestricted ambient operating temperature range of 18C to 32C. Some access immunoassays are affected by ambient temperature changes and can produce inaccurate results when a system is operated within the published range. In the surface matching registration dialogue, if "last solution" after acquisition of additional registration points is selected, the software stores a different registration than the one displayed to the user for verification.
24k Arthroscopy Outflow/Suction Tubing Set
Linvatec Corporation D.B.A. Conmed Linvatec
2011-07-25
2011-07-05 65301
Type II
N/A
A) Synchron LX20 System Analyzer - Class 2 B) Synchron LX20 System Analyzer - Class 3 C) Synchron LXI 725 D) Synchron LX20 PRO A) VectorVision Navigation Software ENT 7.9 B) Kolibri ENT 2.7/ENT Essential 1.0/ENT Unlimited 1.0 Navigation Software C) Kolibri 2.7/Essential 1.0/Unlimited 1.0/VectorVision 7.9 Cranial Navigation Software
2011-07-25
2011-04-18 63157
Type II
A) N/A B) N/A C) N/A D) N/A A) 22076G::VV NAVIGATION SW, 71068::UPDATE VV NAV SW E B) 22201F::KOLIBRI NAVIGATION, 22211::ENT ESSENTIAL NAVI, 22212::ENT UNLIMITED NAVI, 71015::UPGRADE VV ENT 7.9, 71072::UPD KOLIBRI NAV SW C) 22040G::VV NAVIGATION SW, 22204E::KOLIBRI NAVIGATION, 22207::CRANIAL ESSENTIAL, 22208::CRANIAL UNLIMITED, 71011::UPG CRA ESSENTIAL, 71012::UPGRADE VV CRANIAL, 71067::UPDATE VV NAV SW C, 71077::UPG CRA UNL 1.0 FR, 3011996W A) AVA 500 PDL B) AVA 500 TBL
A) All lots B) All lots C) All lots D) All lots A) N/A B) N/A C) N/A
Brainlab AG
2011-07-25
2011-06-10 65093
Type II
Medrad Veris Temperature Sensor Probe A) Avanta Fluid Management Injection System - Main Unit with Pedestal B) Avanta Fluid Management Injection System - Main Unit with Table Mount
Medrad Inc. Medrad Inc.
2011-07-25 2011-07-25
2011-06-06 65096 2011-06-02 65097
Type II Type II
>10 Numbers, Contact Manufacturer A) 20191, 20208 B) 10434, 10458, 10459, 10460, 20017, 20023, 20051, 20145, 20370, 20570
It was discovered that when the impacted temperature sensors are attached to the Veris monitor, the error message 'bad probe' is displayed. There is a software upgrade to the Medrad Avanta Fluid Management Injection System, the upgrade includes the dual line purge software (formerly known as one-touch purge software).
A) Clinac Linear Accelerator B) Trilogy Radiotherapy Delivery System C) Clinac IX Radio Therapy Delivery System D) Novalis TX Linear Accelerator
2011-07-25
2011-03-28 65193
Type II
A) Clinac Linear B) Trilogy C) Clinac IX D) Novalis TX
A) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant B) H291166, H293787, H294551, H140836, H294134, H293883, H291172, H294934, H294403, H294750 C) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant D) H294674 HZ19078, HZ12066, NZ17010
An anomaly has been identified whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail. The falling wedge presents a risk of injury to patients or other personnel in the path of the falling wedge. The risk of failure is proportional to the amount of use of the wedge, and is considered significant only after many years of use. The risk is also increased for heavier wedges, upper wedges used in the interface mount, and for wedges where the screw fasteners are loose or have a history of becoming loose. Varian is aware of this occuring only for 30 degree upper wedges. Other wedges may potentially be susceptible to the same failure. The Optical Guidance Platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations. The optical guidance camera has not been evaluated for stability beyond a 24 hour time period and must be recalibrated at least once every 24 hours. This issue is most likely to be found in units upgraded to the 2.6.x software as older versions of the software allowed users to set calibration time outs greater than 24 hours. However, all users should check their settings as described. In particular, this issue may be found in SonArray Systems where users may have increased the calibration time out beyond the factory settings. Under certain specific circumstances, the gantry rotates in the opposite direction to that specified according to the plan parameters, when moving from one field to the next. If the patient couch or other medical equipment is in the path of the gantry, damage to property or injury to a patient could occur. According to Varian IEC scale, the gantry will rotate clockwise (CW) from 0.0 degrees to 180.0 degrees and counterclockwise from 0.0 degrees to 180.0E degrees. By default, when a user creates an opposing field within a plan that contains static fields, the gantry rotation is set to rotate in the clockwise direction. For situations when that is not desired, a user activated extended angle flag is provided to cause the gantry to rotate in a counterclockwise direction. An anomaly has been identified in the 3D match environment of OBI 1.3, OBI 1.4, OBI 1.5, TrueBeam 1.0 and offline review 1.0 - 2.0 when using reference CT datasets which contain a critical number of slices. [note that the 3D match environments of TrueBeam 1.5 and offline review 2.1 are not affected by this anomaly.] When these reference CT datasets are used to create a reference CT volume in the 3D match environment, in a small number of cases, the scaling of the CT volume will be incorrect and the CT volume will appear larger in the slice direction - than it actually should be. If this improperly scaled CT volume is used for 3D matching, the CBCT volume and patient may be positioned too far superiorly. Because of differences in software design, OBI 1.5 is much more likely to exhibit this behaviour than the other products identified. Certain devices may be unable to create a vacuum due to a component fit that potentially could result in a leak.
Optical Guidance Platform - SonArray Module
2011-07-25
2011-03-28 65193
Type II
97530203A
Aria Practice Management 4D Integrated Treatment Console (4DITC)
2011-07-25
2011-05-27 65197
Type II
V8.1.2, V8.6, V8.8
>10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant
A) On Board Imager B) TrueBeam (Radiotherapy Configuration)
2011-07-25
2011-06-21 65263
Type II
A) OBI B) TRUEBEAM
A) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant B) H191038, H191071, H191044, H191069
A) Mystic II Pump with M-Style Mushroom Cap B) Mystic II Pump with Mitysoft Bell Cup
Coopersurgical Inc.
2011-07-25
2011-06-29 65406
Type III
A) 10057 B) 10058
A) Clinac IX High Energy Linear Accelerator B) Trilogy High Energy Linear Accelerator C) Novalis TX High Energy Linear Accelerator
2011-07-25
2011-03-31 65449
Type II
A) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant B) >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant A) H294383, H294766, H294675, H294683, H294838, H294317, H294364 B) H294551, H140836 C) H294674 >10 Numbers, Contact Manufacturer / >10 Numros, Contacter le fabricant M001724, M009389 XPTG01048
Due to mechanical strain on the coolant line, the coolant system gantry swivel joint may leak into or near electrical components within the gantry or gantry stand housing, creating an electric shock hazard to personnel working within the gantry fiberglass housing, and possibly leading to the failure of the device to operate. Model 1010 sling assembly's sheath and mesh/sheath/sleeve bonding area design may have caused or contributed to certain adverse events, including voiding dysfunction/retention, which in some cases required sling revision or removal. Quality control ranges would shift up for Apolipoprotein B (APOB) reagent lots M011619 and newer with APO CAL (Apolipoprotein calibrator) lots listed. Stryker Medical has discovered that the one-way valve in the EPRT Mattress may have been installed incorrectly and has the potential to result in air escaping out, causing the mattress to sag when weight is placed in the centre. Incorrect labeling on some vials of Free HCGB Calibrator C in lot 607826, a component in the affected pack lots. Due to two software programming errors (version I2.000 and I3.000), a patient record will be linked to an incorrect / inconsistent set of calculation results under specific circumstances. Medtronic Xomed is expanding the original product safety advisory for Medtronic External Nasal Splints and Thermasplints (incident 62165) to advise consignees to immediately discontinue using and dispose of the Skin-Prep Protective Wipes packed together with the affected Medtronic Nasal Splint Kits. The Smith & Nephew Skin-Prep Protective Wipes are contract manufactured by the Triad Group in the same facility where the alcohol wipes, subject to the original field action, are manufactured. Unclear labeling on the product due to the use of an incorrect sterility symbol. This update instruction will help to recognize faulty gradient cable connections and subsequently prevent those from overheating. As part of the UI, thermal sensors (selfadhesive labels) will be attached to the connections identified as critical. The manufacturer has implemented a new onboard stability for some modular analytics reagents (phosphorus, UIBC) as a harmonisation process in order to standardise the open reagent container for all Roche analyzers. The package inserts of the identified products will be modified accordingly. There is a potential patient safety issue when using the Symbia Radiation Therapy Pallet (RTP). The issue occurs when a patient is not ISO-centred before starting a scan and a noncircular orbit is selected.
Universal Urinary Incontinence Sling
Generic Medical Devices, Inc.
2011-07-25
2011-03-15 62622
Type II
1010
Synchron LX Systems APO-B Reagent XPRT Advanced Pulmonary Therapy Surface
Beckman Coulter, Inc. Stryker Medical
2011-07-25 2011-07-25
2011-05-02 63541 2011-06-20 64895
Type III Type III
467905, 469170 2950-100-002
Delfia Xpress 6000 Immunoanlyzer System - Free HCGB Assay Biometer LS 900 Lenstar
Wallac OY
2011-07-25
2011-06-24 65168
Type III
6002-0010, 6002-001C
Haag-Streit, AG
2011-07-25
2011-06-21 65175
Type II
7220096
1060930001, 1060818901, 1060877201, 1060851601, 1060936301,1060947501, 1060857901, 1060931801 NAV, 00070, 00094
Skin-Prep Protective Wipes
Medtronic Xomed Inc.
2011-07-25
2011-06-17 65179
Type II
1528116, 1528126, 1528136, 1529100, 1529110, 1529120
N/A
Merogel Injectable A) Magnetom Aera B) Magnetom Skyra A) Hitachi Phosphorus B) Hitachi Unsaturated Iron-binding Capacity (UIBC)
Anika Therapeutics S.R.L. Siemens AG
2011-08-08 2011-08-08
2011-03-11 62260 2011-06-14 64900
Type II Type II
15-18000 A) 10432914 B) 10432915 A) 11489348216, 11730347216, 11875949216, 11875965216 B) 04361563190, 12146282216, 12146398216
32300, 31700, 31900, 32000, 32100 A) N/A B) N/A A) All lots B) All lots
2011-08-08
2011-06-29 65098
Type III
Symbia T
Siemens Medical Solutions USA, Inc. Molecular Imaging Group
2011-08-08
2011-06-22 65177
Type II
10275010
N/A
Optical Guidance Platform - Optical Positioning System
2011-08-08
2011-03-03 65195
Type II
97525005A
HZ19078, HZ12066, HZ17010
The initial date assigned to the plan is the date of the data transfer. This date is updated when any 'new' file is written into the directory. This date may change when performing other functions with a transferred patient file such as saving pre- recorded positions, fiducial registration, and report or patient settings. Therefore, exam transferred at time 'T' but opened for a quick review in 'T'+T may have the later timestamp leading to confusion at the time of exam selection. The risk is a user opens a previous exam for review and then 'saves' the file. They then go to open today's exam, however they select the most recent exam (the one they just opened, reviewed, and saved) thinking it is treatment plan for the day when it is not. The all in-date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures. During cleaning or desinfecting, it is possible for liquids to enter into the HL 20 - 4 pump console or HL 20 - 5 pump console. If an excessive amount of liquid is used, the liquid can accumulate inside the HL 20 console and drip onto the HL 20 power supply board where it might cause the power supply board to malfunction. In very rare cases, it is possible for a HL 20 twin pump module (TPM) to unintentionally increase its speed for a 1.5 - 2 second period of time before returning to its originally set speed. This malfunction can only occur when the TPM is used for cardioplegia and set up in a master/ slave configuration. During the malfunction, a very transient incorrect mixing of the cardioplegia solution can occur before the pump speed returns to its original setting. This behavior can only occur when one of the TPM pumps is set as cardioplegia slave and the as cardioplegia master pump. When the TPM is used in any other confirguation, this malfunction does not occur. The 2 struts (part # MF0285 downstay) that support the PK7300 cover while in the open position may weaken allowing the cover to fall and strike the analyzer operator. The product contains a higher percentage of phosphoric acid than what is mentioned on the label. The product also continues to extrude from the syringe after pressure is no longer applied. Baxter Corporation is issuing a recall for a single lot of the Interlink system Non-DEPH IV Catheter extension set, as a limited number of individual packages were improperly sealed, which could lead to a compromise in the sterile properties of the packaging.
Synchron Systems Rheumatoid Factor (RF) Reagent HL-20 Perfusion System - Consoles
Beckman Coulter, Inc. Maquet Cardiopulmonary AG
2011-08-08 2011-08-08
2011-06-24 65464 2011-06-29 65466
Type II Type II
475136 706187, 706189, 706193, 706195, 706197, 706199
All in-date lots >10 Numbers, Contact Manufacturer
HL-20 Perfusion System - Roller Pump Modules
Maquet Cardiopulmonary AG
2011-08-08
2011-06-29 65469
Type II
TPM 20-330
Beckman Coulter PK7300 Automated Microplated System (Donor Screening) - Instrument STiK! Etch
2011-08-08
2011-06-27 65471
Type II
PK7300
9010177
Synca Marketing Inc.
2011-08-08
2011-06-07 65543
Type III
SYN/STK12
3505084, 3490709, 3490709, 3490709
Interlink, Non-DEHP IV Catheter Extension Set
2011-08-08
2011-07-08 65550
Type III
2N3375
UR09H05029
V-CATH PICC SL Tray Catheter
Neo Medical, Inc.
2011-08-08
2011-04-12 64396
Type II
301-00
2009092850, 2010012950, 2010030150, 2010043050, 2010061850, 2010062950, 2010082650 A) >10 Numbers, Contact Manufacturer B) 1851840, 1904351
Vials may contain visible particles.
A) Level 1 Normothermic IV Fluid Admin. Sets B) Level 1 F-50 Gas Vent Filter Assembly
2011-08-08
2011-06-21 64851
Type II
A) DI-150, DI-350, DI-65HL, DI-75 B) F-50
Smiths Medical is recalling all level 1 Normothermic IV Fluid Administration Sets equipped with the F-50 gas vent filter assembly (GVFA) from the market and temporarily suspending all sales of these products because of complaints of kinking of the tubing and leaking of the F-50 GVFA. In some cases, kinking in the tubing or leaking of the F-50 GVFA can cause a decrease in fluid flow rate. An anomaly has been identified with the Optical Guidance Platform (OGP) software v2.6 and v2.6.1. this defect causes LAT error of 0.8mm - 1mm for datasets arriving to Optical Guidance Platform (OGP) from eclipse and other planning systems in the left side first orientation. This issue is only applicable to sites using direct eclipse or other non fastplan 3rd party treatment planning software that send data in true dicom format. This issue affects body array, frameless array and frameless array SRS. Smiths Medical is providing a safety alert to advise its customers of the attached customer information bulletin 05-05-11, that provides additional information for correctly latching the CADD Medication Cassette Reservoir or administration set to the pump. Smiths Medical has become aware of small number of complaints of significant under-delivery/non-delivery of fluids when the cassette is not correctly latched to the pump. Baxter Corporation is recalling a single lot of the product because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient. When using sequencer with the Lantis Oncology Information System, the error comes up if Lantis cannot insert a new record. Philips has become aware that under certain circumstances, edits to an order can result in unintended scheduled interventions on the Intellivue Clinical Information Portfolio. If the clinical team does not recognize that such unintended interventions are scheduled in ICIP order management, a patient may receive interventions or additional medication doses that are not intended. Due to a software anomaly, the camera may intermittently shut off causing a loss of fluoroscopy, resulting in an interruption of the examination. In the service mode, the "source alignment procedure" can be started with the door physically open as well as with the doorswitch on Linac. This could potentially expose the operator to radiation. Potential for the sterile barrier to be compromised. When the contents of faxed reports have been verified, they found one of the specimen diagnosis to be missing. Parts A through D were present as well as part F, however part E diagnosis was missing. Some units of Theralite High Cut-off dialyzer from lot1-082 may have an incomplete seal of the sterile bag. It is possible that a compromised sterile barrier could go unnoticed and an unsterile product could be used on a patient. Edwards Lifesciences has become aware of possible separation of the Introducer Sheath from the hub. The Introducer (IntroCSC) is packaged with the EndoPlege Coronary Sinus Catheter (EP). If the sheath becomes detached from the hub, surgical intervention may be required to retrieve the sheath.
Optical Guidance Platform - Optical Positioning System
2011-08-08
2011-03-30 65196
Type II
97525005A
HZ19078, HZ12066, HZ17010
CADD-Solis Ambulatory Infusion Pump
2011-08-08
2011-07-04 65303
Type II
21-2101-0200-02, 21-2101-51, 21-2102-51, 21-2111-0100-51, 21-2111-0200-02
Epidural Solution Administration Set Updated recall # 64503 previously posted on 2011-06-27. / Mise jour du retrait # 64503 affich le 2011-06-27.
2011-08-08
2011-06-03 64503
Type II
2C7554S
GR293209, GR291559
Lantis
Siemens AG
2011-08-08
2011-06-30 65472
Type II
4503178
N/A
Philips Medizin Systeme Boeblingen GMBH
2011-08-08
2011-07-11 65590
Type II
N/A
N/A
EasyDiagnost Eleva Flexitron HDR Afterloader
Philips Medical Systems DMC GMBH Nucletron B.V.
2011-08-08 2011-08-08
2011-07-13 65596 2011-06-01 65038
Type II Type II
426058 136149A01
N/A N/A
A) Sofsilk Non-Absorbable Silk Sutures B) Ticron Non-Absorbable Polyester Sutures SoftPath GUI v. 4.3.0.10-11-12
Covidien LLC SCC Soft Computer
2011-08-08 2011-08-08
2011-06-07 65090 2011-07-07 65682
Type II Type II
A) 2-0 (GS62M), 3-0 (GS33M), 3-0 (GS63M) B) 3259-62 (8886325962) 566698
A) N/A B) N/A N/A
Theralite High Cut-Off Dialyzer
Gambro Dialysatoren GMBH
2011-08-08
2011-07-15 65588
Type III
113092
1-082
EndoPlege Coronary Sinus Catheter
2011-08-08
2011-07-11 65591
Type II
EP
A) Rusch Female Catheter B) Robinson/Nelaton PVC Catheter Architect System - C-Peptide Assay A-dec 311 Dental Chair
Teleflex Medical
2011-08-08
2011-07-11 65593
Type II
ABBOTT LABORATORIES DIAGNOSTIC DIVISION A-dec, Inc.
2011-08-08 2011-08-08
2011-07-12 65594 2011-03-03 65645
Type II Type II
A) 238300080, 238300100, 238300120, 238300140, 238300160 B) 238500100, 238500120, 238500140, 238500160, 238500180, 238500200, 238500220, 238500240 03L53-25 311
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer 01711A000 N/A
The urology catheters are being recalled because the packaging may be compromised and therefore the sterility of the product cannot be guaranteed. C-Peptide lots have the potential to generate falsely elevated results with certain patient samples and with non-Abbott controls. Abbott controls are not impacted. A-dec inc received reports indicating articulating headrests had failed. The company found out that the mechanism of the headrests may fail, potentially causing a sudden and unexpected loss of holding force. There is a typographical error on the supplemental unconfirmed typings for Cell 9 (donor b1356). The donor is listed as RG+ and should be listed as RG-. The accompanying master list correctly lists Cell 9 as RG- in the Special Type column. A small temperature deviation that was observed with two products during transportation. The temperature decrease was shown to come from some dry-ice shipments.
Panocell-16
Immucor Inc.
2011-08-08
2011-07-18 65738
Type II
2332
24019
A) Elecsys Ferritin Roche Diagnostics GMBH B) Online TDM Carbamazepine (CARB2) for Cobas C System
2011-08-08
2011-05-06 63730
Type III
A) 03737586190 B) N/A
A) 16095101, Specific Shipment Only B) 63884401, Specific Shipment Only
Ultra View Universal DAB Detection Kit
Ventana Medical Systems Inc
2011-08-08
2011-05-16 64948
Type II
760-500, ROCHE CAT # 05269806001
A05885, B00988
A) Cobas Integra System - Salicylate B) Roche Hitachi / Salicylate C) SALI (Salicylate for Roche/Hitachi Cobas C311 and C501/502 Systems) A) Eclipse Ocular Proton Planning V1.1 B) Eclipse Smart Segmentation C) Rapidarc, also known as Dose Dynamic Arc D) Eclipse TPS V8.8
2011-08-08
2011-07-11 65702
Type II
A) 20753580322 B) 11815172216 C) 20753580322 A) TPA001075000 B) TPA001094000 C) UP9001 D) 100042024
A) All lots B) All lots C) All lots A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) H48A478, H48C062, H48C063, H48A242
Ventana Medical System Inc has identified the presence of precipitates in DAB Chromogen Dispensers associated with Ventana DAB Detection kits. It may result in light to no staining on some slides which could result in a false negative diagnosis. Update the interference claims of the Salicylate Assays for use on Cobas Integra, Roche/Hitachi and Cobas C Analyzers.
2011-08-08
2011-05-03 65752
Type II
An anomaly has been identified with certain AAA versions where the second source modeling for IMRT fields with Multiple Carriage Groups is incorrect. In affected AAA versions when modeling the second source, the Collimator Jaw positions are read from the first control point of the field. This can cause an underestimation of the dose when calculating an IMRT field which has Multiple Carriage Groups. When the plan is delivered the delivered dose can be higher than planned locally by up to 10%. The Blood Pressure (BP) cuffs may not properly inflate due to a leak.as a result, the BP cuff may indicate an incorrect blood pressure reading.
Cuff-Able Blood Pressure Cuff
Vital Signs Inc.
2011-08-08
2011-07-08 65773
Type II
All, BP101020, BP101520, BP101720, BP102020, BP151020, BP151520, BP151720, BP152020, BP201020, BP201520, BP201720, BP202020
N/A
A) Cuff-Able Blood Pressure Cuffs B) Broselow/Hinkle Pediatric Emergency System Kits Oxygen Masks C) Broselow/Hinkle Pediatric Emergency System Flying Carpet - Cuffable BP Cuffs D) Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Module - Oxygen Masks E) Broselow/Hinkle Pediatric Emergency System Pouch, Bag and Tag Pack - Cuffable BP Cuff
Vital Signs Inc.
2011-08-08
2011-07-08 65774
Type II
A) BP4030BR B) 7730ALS, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5 C) 7730FLY D) 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2 E) 7730POCH
A) N/A B) N/A C) N/A D) N/A E) N/A
The manufacturer of the oxygen mask, UnoMedical, conducted a field corrective action to address a potential sticky substance on the inside and/or outside of the mask, included in the vital signs Broselow Pediatric Emergency System kit. Blood pressure cuffs also included in the vital signs Broselow Pediatric Emergency System kit may not properly inflate, which may result in an incorrect blood pressure reading.
Aria Software
2011-08-08
2011-05-17 65826
Type II
N/A
HIT0040, HIT0606M, HIT0606R1, HIT2414M, HIT2414R1
Using the RT chart function in Aria, versions 8.0 and 8.1 when users select the "convert to set-up field" option, a set-up field is created, that removes the DMLC (Dynamic Multi Leaf Collimator) plan components in order to create an open collimator for field light setup purposes. In a recently reported case, a user, having selected this option in error, then converted the setup field back to a treatment field. The resulting treatment field is then missing the DMLC. If this error is not detected prior to patient treatment, open field treatment can result. The devices were imported into and/or sold in Canada prior to receiving regulatory approval by Health Canada.
A) Elucigene CF-EU1 B) Elucigene CF29 w/o TAQ - 50 Test Kit C) Elucigene CF-EU2 - 50 Test Kit D) Elucigene CF-EU2 - 10 Test Kit E) Eluciegene TRP - 50 Test Kit Luxstar Dental Light
Gen-Probe Life Sciences Ltd.
2011-08-08
2011-06-10 64649
Type II
CF1EUB2, YF029B2, CF2EUB2, CF2EUBX, TH003B2
N/A
Dental Equipment LLC. DBA Marus
2011-08-08
2011-06-24 65582
Type III
N/A
ML1000, OL1000, CL1000, UL1000, TL1000
Dental Equipment LLC Marus became aware via 16 external failures that the Lens Heat Sheild (Birdcage) could fail and injure a patient if not properly installed or maintained. Medtronic has initiated a recall of two lots of Pedicle screws used for spinal surgery because they were etched with the wrong screw length. It was discovered that the screws are actually longer than the etching states. The error was determined to be due to human error in the manufacturing process. The Infusors may leak and not apply the desired pressure to the I.V. solution bag and subsequently the rate of infusion may be inadequate. If used in conjunction with an arterial pressure line for the purpose of measuring blood pressure, a potential falsely low blood pressure reading may result. This issue may impact patient safety. Becton Dickinson has determined that a quantity of product, packaged within experimental shelf cartons made of recycled cardboard, was released to consumers within Lot 0039920. Each of the experimental shelf cartons is labeled with an orange "change control" sticker, identifying it as the experimental material. Note: only the outer packaging, shelf carton material was "experimental". The actual syringe products, and inner sterility barrier packaging, were all the correct, qualified materials. The recall was initiated at the request of Health Canada because Ormco Corporation was unable to provide data which would assure the product's sterility as per the sterilization methods detailed in the instructions for use.
A) CD Horizon Legacy Multi-Axial Screw B) Vertex Cortical Screw
Medtronic Sofamor Danek USA, Inc.
2011-08-08
2011-07-08 65589
Type II
A) 75445540 B) 69004440
A) H09E6272 B) H05J2843
Infusable Pressure Infusor
Vital Signs Inc.
2011-08-08
2011-05-17 65772
Type II
IN800012, IN900012, IN950012
N/A
Becton Dickinson 1ml 28g Insulin Syringe with Needle
Becton Dickinson and Company
2011-08-08
2011-06-17 65794
Type III
N/A
39920
MadaJet XL Part Number 601-0000
Ormco Corporation
2011-08-08
2011-07-01 65825
Type III
N/A
601-0000
12-Lead ECG cable
Physio-Control Inc.
2011-08-22
2010-05-24 64026
Type II
11111-XXXXXX
3302822-000-AHA, 3302822-002-AHA, 3302822- The purpose of this field action is to notify customers who own 12-lead ECG cables that 001-IEC, 3302822-003-IEC, 3302823-000-AHA, were distributed between October 5, 2010 and May 3, 2011 of important storage and 3302823-001-IEC handling instructions. The notification letter will bring attention to and provide storage and handling instructions to users.
A) RAPIDpoint 400 System B) Blood Gas System-Control Reagents C) 840/845 Blood Gas System-Control Reagents D) 348 System-Reagents E) 860/865 Blood Gas System-Control Reagents F) RAPIDQC Complete Level 1 G) RAPIDQC Complete Level 2 H) RAPIDQC Complete Level 3 LIFEPAK 500 Automated External Defibrillator
2011-08-22
2011-06-13 64866
Type III
A) 108860, 108868, 108869 B) 108860, 108868, 108869 C) 108860, 108868, 108869 D) 108860, 108868, 108869 E) 108860, 108868, 108869 F) 108860 G) 108868 H) 108869 3005332, 3005335, 3005338, 3005339, 3005343, 3005379, 3005380, 3005381000, 3005381-001, 3005381-002, 3005389, 3005400, 3005578, 3006007, 3006535, 3009767, 3010697, 3010698, 3010779, 3011019-000, 3011020, 3011111, 3011520, 3011790, 3200390, 500, 803499-00, 803499-09, 805662
A) 361004, 362003, 362004, 363003 B) 361004, 362003, 362004, 363003 C) 361004, 362003, 362004, 363003 D) 361004, 362003, 362004, 363003 E) 361004, 362003, 362004, 363003 F) 361004 G) 362003, 362004 H) 363003 >100 lot numbers Contact Manufacturers
There is an error in the package insert pertaining to the Co-Oximeter parameters of the RAPIDQC Complete controls. RAPIDpoint 405 system values and barcodes were transposed with those of the RAPIDlab 800 series system. RAPIDlab 1200 system values for neonatal bilirubin are incorrect.
Physio-Control Inc.
2011-08-22
2011-06-17 64896
Type II
A field alert regarding apotential reliability issue is the result of a design characteristic of a SRAM (static random access memory) electronic component on the main printed circuit board assembly. This particular component can be susceptible to moisture ingress resulting in a potential malfunction. If this occurs, the Lifepak 500 device can fail to turn on. The purpose of this correction is to notify customers who own Lifepak 500 aeds of this potential issue and provide guidance for device storage practices that may exacerbate the issue. During the card loading process, the sealer card pusher assembly could inadvertently make contact and move a cassette up to three card slots when the vacuum chamber is lowered, which then causes the cassette to be out of alignment with the carousel incubator. As a result of this misalignment, cards may be loaded into the carousel incubator in the wrong order resulting in mismatched results, incorrect results or delay in treatment due to the need to set up new cards. Certain lots of the elution buffer has engendered calibration failures and late retention times. Ortho clinical diagnostics received a customer complaint regarding a misread of a sample identification (ID) number when using the external hand-held Heron Datalogic D-130 barcode scanner with the Ortho Provue Analyzer. Under certain conditions the barcode id displayed on the Ortho Provue Analyzer screen may not match the barcode on the sample tube (i.e., the expected 6-digit barcode may be converted into a 9-digit barcode). Software versions 2.004 and earlier for the DDU-100 series AEDs ("Lifeline") may be affected by 1 or 2 conditions which in rare cases may cause an affected AED to cancel shock during the charging process and not deliver therapy. Thomas Medical Products has become aware that in some instances the pouch seal that maintains the sterility of the product may be weak or open and compromise the sterile barrier.
A) VITEK 2 System - VITEK 2 Instrument B) VITEK 2 System - VITEK 2 XL Instrument
bioMrieux Inc.
2011-08-22
2011-06-07 65099
Type II
A) 27225 B) 27227
A) VTK23119 to VTK23754 B) VTK2XL2129 to VTK2XL3264
D-10 Dual Program Reorder Pack Ortho Provue Analyzer
Bio-Rad Laboratories Diagnostics Group Micro Typing Systems Inc
2011-08-22 2011-08-22
2011-07-15 65741 2011-07-21 65840
Type II Type III
2200201 MTS213784
20010663, 20010665 >10 lot numbers Contact Manufacturers
Defibtech Lifeline DDU-100 Semi-Automatic External Defibrillator A) H.Lee SafeSheath Subclavian Introducer B) H.Lee SafeSheath Sealing Adaptor C) Transvascular Insertion Tool
Defibtech LLC
2011-08-22
2011-03-11 62337
Type I
DDU-100A, DDU-100E
N/A
Thomas Medical Products, a GE Healthcare Company
2011-08-22
2010-12-20 60649
Type II
A) HLS-1006, HLS-1007, HLS-1009, HLS-1009.5, HLS-2507, HLS-2509, M209535008, M209535-013, M209535-015 B) MA02158A-008, MA02158A-012, SSSA-09, SSSA-EW-09 C) M930066A-001, TVI-07
Dicom Q/R version 1.1.4 software
Medtronic Navigation Inc.
2011-08-22
2011-06-01 64368
Type II
version 1.1.4
A) S32159, S32993, S33083, S33308, S33309, S32931, S32924 B) S33079, S32071, S32205, S32359, S33344, S33486, S33752, S33346, S33485, S33753, S32778+H16 C) S33557, S32830, S33028, S33628, S32606, S33388, S33938 N/A
Medtronic Navigation is implementing a voluntary field correction of Dicom Q/R version 1.1.4 that is used to transfer patient exams from a PACS system to the Stealthstation. All systems installed with Dicom Q/R version 1.1.4 will be upgraded to version 1.1.5. Some kits of the Advia Chemistry HBa1c Calibrator Lot V43263 may have mislabelled vials of level 5 and 6 calibrator. Also, Advia Chemistry A1C Calibrator Lot V41716 may have mislabelled vials of level 1 and 2 calibrator. Upon close examination of the Victory 10, it was determined that a batch of fuses were not manufactured up to specifications. This could potentially lead to a unit failure or a fire due to a fuse malfunction. Biosense Webster Inc. (A Johnson & Johnson Company) recently became aware that the Stockert EP Shuttle System release notes describing software anomalies for Versions 1.035 and 1.037 were not previously communicated or provided to all customers. The field notification is being issued to all customers to provide them with release notes. 1) Inline post-processed (i.e. automated postprocessing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool Fibertrak do not match with the orientation annotations under some conditions. 1) Inline post-processed (i.e. automated postprocessing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool Fibertrak do not match with the orientation annotations under some conditions. Microm has identified a need to enhance the safety instructions and the description of the devices in the safety manual regarding safe work practices as well as the addition of a new quick-reference-card. Calibrator solutions F & A2 give lower than expected values for calibration.
A) Advia Chemistry System-Hemoglobin A1C (A1C) Assay Siemens Healthcare Diagnostics Inc. B) Advia Chemistry System-Hemoglobin A1C (HBA1C) Assay
2011-08-22
2011-06-28 65465
Type III
A) 06854752 B) 06628018
A) LOT V41716 B) LOT V43263
A) Victory 10, 3 Wheel (SC610) B) Victory 10, 4 Wheel (SC710) Stockert EP Shuttle System
Pride Mobility Products Corp
2011-08--22
2011-07-12 65743
Type II
A) SC610 B) SC710 39D76X
A) >100, Contact manufacturer B) >1000, Contact manufacturer >10 lot numbers Contact Manufacturers
Stockert GMBH
2011-08-22
2011-07-19 65913
Type III
A) Discovery MR750 B) Discovery MR450 C) Optima 450 WD D) Optima 450 WE Optima MR360 1.5T
2011-08-22
2011-07-05 65949
Type II
A) M7000BH B) DISCOVERY MR450 1.5T MR S C) M7000WD D) M7000WE 5312366 (M50002BB)
A) N/A B) N/A C) N/A D) N/A N/A
GE Hangwei Medical Systems Co. Ltd.
2011-08-22
2011-07-27 65950
Type II
Thermo Scientific Rotary Microtome HM355S-3
Thermo Anatomical Pathology Microm
2011-08-22
2011-07-07 65959
Type II
HM355S
44828, 44829, 45411, 45429, 45430, 45708, 46101, 46269, 46277, 46324, 46325, 46326, 46974, 46975, 46976 BCAL05R
G7 Automtated Glycohemoglobin System - F & A2 Calibrators TOSOH Corporation
2011-08-22
2011-07-25 65968
Type III
20019
Howmedica Modular Resection System - Proximal Tibia
Howmedica Osteonics Corporation
2011-08-22
2011-07-06 65586
Type II
N/A
>10 lot numbers Contact Manufacturers
Tendon Stripper
2011-08-22
2011-07-19 65769
Type II
N/A
>10 lot numbers Contact Manufacturers
Atlantis Cervical Plate System Self-Tapping Screw Module ("Screw Caddy")
Medtronic Sofamor Danek USA, Inc.
2011-08-22
2011-07-19 65942
Type II
176-513, 976-516
All Lots
Stryker Orthopedics has initiated a product recall for the Howmedica Modular Resection System - Proximal Tibia. This is in regards to a non-conformance: Due to the presence of excessive material at the base of the slot feature in the distal femoral component as observed on the returned per device. It has been identified that the shaft tip material (casting) does not meet the Smith & Nephew, Endoscopy Division 416 material specification, and therefore results in the rusting of the distal end of the tendon stripper. It was discovered that the screw gauge located in the lower left corner of the screw caddy used with the Atlantis Spinal System may not meet print specifications. It has been observed that in some cases, the lines on the gauge were not placed on the caddy according to specification, which could cause a screw to be measured improperly. An incorrect gauge has been shown to measure a screw to be approximately 1mm shorter than the actual screw length. This recall does not affect the new Atlantis Screw Caddy released when the Universal instruments were launched in 2010. GE Healthcare has become aware that image orientation of reference series displayed in FuncTool Diffusion Tensor/Fibertrak Protocol on Advantage Workstation MRI applications may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.
Advantage Workstation with FuncTool version 6.3xx-9.3xx
2011-08-22
2011-08-23 65987
Type II
5126889-X
N/A
Direct Drive Grasper
Applied Medical Resources Corporation
2011-08-22
2011-06-24 65944
Type II
C4130
1126120, 1137511, 1127581
Possible discrepancies in the in the material drying time and consequent injection molding. Parameters during the manufacture of the respective locking trigger lots. As a result of these non-conformities, there is potential.for the locking trigger to fracture during usage and allow the grasper to remain in a closed position. All units/kits that were built with the suspect lots of triggers have either been put in quarantine or are included in the recall.
PSM Software
Roche Diagnostics Ltd
2011-08-22
2011-07-18 65956
Type I
4944607001
All serial numbers
PSM Software
Roche Diagnostics Ltd
2011-08-22
2011-07-18 65957
Type I
4944607001
All serial numbers
A) MagNA Pure LC 2.0 Instrument - Software version 1.1.23 and 1.1.24 B) MagNA Pure LC 1.0 Instrument - Software version 3.0.11
2011-08-22
2011-07-25 65960
Type III
A) 05197686001 B) 12236931001
A) Software version v1.1.23, Software version v1.1.24 B) Software version 3.0.11
When used with QC and Validations modules, the PSM version 2.02.02b and 0.02.02c can release patient results when they should actually be blocked for release by a QC Result Failure. When using car rules, there is a possibility of the result being released to the LIS (Laboratory Information System) prior to performance of the action dictated by the CAR rule. This could result in unintended premature release of results, or release of results prior to the addition of critical information such as flags or comments. Software malfunction causing liquid handling problems observed with Magna Pure LC 1.0 Instrument (Software version 3.0.11) and Magna Pure LC 2.0 Instrument (Software versions 1.1.23 and 1.1.24).
CK-3 Large Full Radius Scalpel
Ormco Corporation also trading as Sybronendo
2011-08-22
2011-05-18 63869
Type III
975-0011
100813
Omnidiagnost Eleva Plastic Needle with Mandrin
Philips Medical Systems Nederland B.V. Varian Medical Systems, Inc.
2011-08-22 2011-08-22
2011-06-12 65597 2011-07-13 66002
Type III Type II
708027 GM11007560, GM11007570, GM11007580
N/A >10 lot numbers Contact Manufacturers
One lot of scalpel packages labeled as CK-3 Large Full Radius Scalpel, Part# 975-0011, actually contained CK-6 Small Full Radius Scalpel. The package listed the correct part number, but included the incorrect part. Due to a software anomaly, the camera may intermittently shut off causing a loss of fluoroscopy, resulting in an interruption of the examination. Previous Recall (53838) addressed needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. Recall 66002 supplements and modifies previous notice,where users are instructed to stop using any plastic needles they may have in inventory with Lot numbers C01 to D01 and those with Lot numbers which start with H or I. This recall also requires users to return any plastic needles with Lot numbers C01 to D01 and those Lot numbers which start with H or I to Varian Brachiotherapy for replacement with plastic needles starting with lot J or higher.
Neptune 2 Waste Management System - Rover
Stryker Instruments
2011-09-05
2011-07-25 65943
Type III
0702-001-000
733700353
Stryker Instruments has received reports of casters failing in the field. The caster failures have resulted from the "swivel head of the caster which is a double ball bearing composed of polyamide that loosens over time" creating excessive swivel play. The resultant swivel play allows the caster to bind/jam with the chassis of the rover when force is applied by the operator to move the device.
Synchron LX Systems Apoa Reagent Coulter DXH Cell Lyse
Beckman Coulter Inc. Beckman Coulter Inc.
2011-09-05 2011-09-05
2011-08-01 66071 2011-08-01 66072
Type III Type III
467900, 469170 629029
M101837, M009389
TempSpan CMT A) 37% Phosphoric Acid Etching Gel B) Etch Gel C) Cement-It - Cementation System Kit D) Mojo Veneer Cement
Kerr Corporation, also trading as Pentron Clinical Kerr Corporation, also trading as Pentron Clinical
2011-09-05 2011-09-05
2011-05-18 66108 2011-05-17 64744
Type III Type III
N69CA A) N10 B) N01H, N01IB, T06, T06A, T06B C) N33 D) N06K
Beckman Coulter Inc. identified lot-to-lot shifts in patient results when switching lots of Apoa Reagent or Apo Calibrator. 0710001, 0710002, 0710003, 0710004, Beckman Coulter Inc. identified elevated background counts in the Coulter DxH Cell Lyse. 0711001, 0711002, 0711003, 0712001, 0712002 As a result of the elevated background counts, the Bodyfluids Control Level 1 is not recovering within range. 3748413 Received complaints of dark stain under product when temporary crown was removed and that product did not set. A) All made since Apr 2007 with expiry btwn It was discovered that the product continues to extrude out of the syringe even after 2011/04-2015/04 pressure is no longer applied. The affected products actually contain 45% phosphoric acid B) All made since Apr 2007 with expiry btwn rather than the correct 37%. 2011/04-2015/04 C) All made since Apr 2007 with expiry btwn 2011/04-2015/04 D) All made since Apr 2007 with expiry btwn 2011/04-2015/04 238928, 235991 1102034555 to 1102034560 There has been an increase in the number of unexpected positive thc results. Stryker Medical has determined that the brake rod assemblies of the above referenced stretcher models that are built with a "5th wheel" series stretcher base were manufactured with roll pins that did not meet the material specifications. Accordingly, some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overall brake holding force. The Vitek 2 Systems bioArt rules that enforce the limitations of Cronobacter Sakazakii (c. Sakazakii) are not included in the pre-defined bioart limitation rules released in the version 5.01 software. Enterobacter Sakazakii was moved out of the Enterobacter species group and renamed to c. Sakazakii group. These pre-defined bioArt rules were not updated to include c. Sakazakii group, therefore the rules are not appropriately applied when the organism identification is c. Sakazakii group. Beckman Coulter Inc., identified access total T4 calibrator Lot 021654 do not meet their 12 month expiration date claim. Patient and quality control results may be falsely decreased by 2 standard deviations or more. This decrease may be seen as early as ten months prior to the labeled calibrator expiration date.
Triage Drugs of Abuse Plus TCA Test Kit 30" Transport Stretcher
Alere San Diego, Inc. Stryker Medical
2011-09-05 2011-09-05
2011-07-01 65583 2011-07-28 65795
Type III Type III
168406 0748-000-000
A) VITEK 2 Compact 30 System B) VITEK 2 Compact 60 System C) VITEK 2 System D) VITEK 2 XL System
bioMrieux Inc.
2011-09-05
2011-07-25 65958
Type III
A) 27530 B) 27560 C) 27225 D) 27227
A) Access Immunoassay Systems Total T4 Calibrators B) Unicel DXI 600 Access Immunoassay System - Total T4 Assay C) Unicel DXI 800 Access Immunoassay System - Total T4 Assay Breeze Self-Adhesive Resin Cement Wick Lip Bumper Mini Twin Brackets-left and right Spider 2 Limb Positioner
Beckman Coulter Inc.
2011-09-05
2011-07-25 65988
Type III
A) 33800, 33805 B) 33800, 33805 C) 33800, 33805
A) Total T4 Calibrators 021654 B) Total T4 Calibrators 021654 C) Total T4 Calibrators 021654
Pentron Clinical Technologies, LLC Ormco Corporation Ormco Corporation Smith & Nephew, Inc., Endoscopy Division
2011-09-05 2011-09-05 2011-09-05 2011-09-05
2011-07-21 66129 2011-07-29 66136 2011-07-29 66138 2011-07-28 66017
Type II Type III Type II Type II
N97A 293-0162, 293-0163 329-0350, 329-0351 72203299
3558203, 3581367, 3564511, 3538478 041158162, 041158163 031157404, 041173689, 3673684 73, 79, 80, 99, 103, 104
Possible curing problem with cause cemented crowns to fall off after use of product. Complaint indicating the Wick Lip Bumpers had hooks that were welded reversed. Mini Twin Brackets were labeled as having no hooks actually contained Mini Twin Brackets with hooks. It has been identified that the Spider 2 Limb Positioner may unlock (loss of traction) resulting in the potential movement of the patient when the device is within close proximity to an RF (radiofrequency) source. Loss of traction can potentially result in the unintended repositioning of the extremity within traction. There is a potential for tissue or cartilage damage to occur due to the unexpected and sudden repositioning. Field advisory notice intended to further educate all users on certain aspects of the device.
Mizuho OSI Modular Table Systems
Mizuho Orthopedic Systems, Inc.
2011-09-05
2011-08-04 66074
Type III
5803, 5855, 5927, 5943, 5943-AP, 5943APNC, JTS, MTS, OITSITS, OTS
All Serial Numbers
Aixplorer Ultrasound System - Main Unit
Supersonic Imagine
2011-09-05
2011-08-04 66102
Type II
SSIP90019
SIB5127, SIB5128, SIB5129, SID0918, SID2531, SIC4724
A) ReNew Long Fenestrated Grasper B) ReNew Super-Atrau Fenestrated Grasper
Microline Surgical, Inc.
2011-09-05
2011-07-18 66154
Type II
A) 3262 B) 3642
A) 00105332 B) 00105709
A problem occurs within the Aixplorer V4.2 Software when using the TAMV (Time Average Mean Velocity) tool in PW mode. When used under certain conditions, the calculation of the mean velocity value, deduced from the peak value, could be erroneous. Therefore, the TAMV calculation displayed on the monitor is incorrect. The ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper).also, the ReNew product number 3642 (Super-Atrau Fenestrated Grasper) was packaged and labeled as 3262 (Long Fenestrated Grasper). One lot has not camphorquinone resulting is a clear, rather than yellow colour. Product will perform as intended. When lens heat shield of dental light is not properly installed or maintained, it my fall and burn/cut the patient in dental chair. Some non-conformances have been identified that have the potential for the locking trigger to fracture during usage and allow the grasper to remain in a closed position. During Dicom export of plan level images with a non square exported Field of View (FOV), an anomoly in the process of squaring the plan level image may cause the image to shift with respect to ROI's and dose. When the anomoly occurs, the magnitude of the image shift can be a full IEC-X Voxel, a full IEC-Z Voxel, or full Voxels in both IEC-X and IEC-Z. I-Flow Corporation determined that approximately 0.4% of On-Q Pumps with Select-A-Flow may develop a minor leak. If a leak occurs, it may not be detected during filling or priming of the pump. When lens heat shield of dental light is not properly installed or maintained, it may fall and burn or cut the patient in dental chair. The tubing packaging used to package these items appeared to be oversized and could potentially allow the end caps to come loose, enabling the product to puncture the sterile packaging.
OptiBond FL Marus LuxStar Dental Light Direct Drive Disposable Laparoscopic Grasper Tomotherapy Treatment System-Kit Power
Kerr Corporation Dental Equipment, LLC DBA. DCI Equipment Applied Medical Resources Corporation Tomotherapy Incorporated
2011-09-05 2011-09-05 2011-09-05 2011-09-05
2011-07-07 66168 2011-06-11 66172 2011-06-22 66179 2011-07-13 65771
33352 CB1000, CL1000, ML1000, OL1000, TL1000, UL1000, WL1000 C4130 101264
>10 Lots, Contact Manufacturer All lots distributed between 2004/04-2010/12 1126120, 1137511, 1127581 N/A
ON-Q Pumps with Select-A-Flow
I-Flow Corporation
2011-09-05
2011-08-09 66207
Type III
CB004, CB005, CB6007
032678, 992877, 9C2263, 9C2326
Marus Luxstar Dental Light A) Twist Drill Bit B) Tip Threaded Guide Pin C) Guide Pin Bayonet Point D) Guide Pin Trocar Point E) Peri-Loc Periarticular System - K-Wire with Trocar Point F) Swanson Finger Wire G) Cobalt Chrome Trochar Tip Wire H) Cobalt Chrome Drill Tpe Threaded Wire I) Cobalt Chrome Drill Tip Wire J) Drill
Dental Equipment, LLC DBA DCI Equipment Smith & Nephew Inc.
2011-09-05 2011-09-05
2011-06-11 65582 2011-07-06 65948
Type III Type II
N/A A) 71134064 B) 71123200 C) 128039 D) 128047 E) 71161012, 71161016, 71161020 F) 128145, 128147 G) 71101507, 71101509 H) 71101504, 71101505 I) 71101503 J) 71173801, 71173803, 71173805
ML1000, OL1000, CL1000, UL1000, TL1000 A) 10EM07430 B) 10DM17100 C) 10EM11762, 10FM12052, 10FM11506 D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) 10EM05885, 10EM05897, 10FM15942, 10GM01542 G) 10GM01572, 10GM01568 H) 10GM01559, 10EM11863 I) 10EM11858 J) >10 Numbers, Contact Manufacturer 1011103570, 1011103604, 1007103265, 1007103205
Slidex Staph Plus
bioMrieux Inc.
2011-09-05
2011-08-09 66152
Type III
73115, 73116
A) Senographe DS Full Mammography System B) Senographe Essential Mamography System SoftPath GUI versions 3.17.5 to 3.17.9, 4.2.1 to 4.2.3 and 4.3.0 to 4.3.0.4
2011-09-05
2011-08-02 65770
Type II
SCC Soft Computer
2011-09-05
2011-07-13 66148
Type II
A) S30321JR A) All B) 5144816, 5144816-1-1, 5144816-3, 5144816-4, 5144816-5, 5144816-6, B) All 5144816-7, 5144816-8, 5144816-9, 5144816-9E SOFTPATH GUI VERSIONS 3.1>,SOFTPATH GUI VERSIONS 4.2>, SOFTPATH N/A GUI VERSIONS 4.3>
Further to complaints, the manufacturer's investigation have detected a problem with certains lots of R1 reagents specificity (Anti-Staphylococcus Aureus Latex) leading to false positive results with Staphylococcus Non Aureus strains. Measurements on magnification images at different workstations, e.g. Siemens or RA1000, lead to different results. There is a Dicom Tag Image error. For clients using AP Macros or Datafields inside Report Template Document Section that save to the database, the data may not be correctly updated in the database.
FlexCath Steerable Sheath, Model 3FC12
Medtronic Cryocath LP
2011-09-05
2011-07-19 66159
Type II
3FC12
This field notification is to inform affected customers of an observation related to a potential leak in the hemostatic valve of the FlexCath 12 Steerable Sheath, Model 3FC12, and provided information on the best approach to recognize and manage the observation. In May 2011 the rate of occurrence of hemostatic valve leaking related issues rose from 0.35% to 2.47%. the reported failures are hemostatic valve leaking and air ingress during aspiration. Due to the design difference of the 12 French sheath from the 10 French sheath and the increase in the rate of occurrence being specifically related to the 12 French model of the FlexCath Sheath, the communication is being focused on the 12 French Sheath Model.
SoftPath GUI versions 4.2.3.3 to 4.2.3.6 and 4.3.0.5 to 4.3.0.12 NeuroTrac MyoPlus2
SCC Soft Computer
2011-09-05
2011-07-20 66258
Type II
SOFTPATH GUI VERSIONS 4.2>, SOFTPATH GUI VERSIONS 4.3>
N/A
Verity Medical Ltd.
2011-09-05
2011-06-01 65964
Type III
MY0220
2011 MYO220 001
For clients using a customized lab results ap macro or a micro results results ap macro in the patient report template, there is a possibilility that the lab tests displayed may be only for the first order from the date range for the patient. An anomaly was found in the software in a limited number of MyoPlus 2 devices. In certain circumstances (both stimulation channels turned up, the difference in intensity between the channels is more than 5 MA), this anomaly can cause the muscle stimulation output of channel 1 to stop increasing when the display on the lcd passes 45 MA. Even though continued pressing of the channel 1 "MA+" control button increases the reading on the lcd display up to the maximum of 90 MA the actual output stays at 45 MA. However, if and when the intensity of channel 2 is increased, as you pass 47 ma, channel 1 immediately corrects itself so that the output MA is the same as the lcd display for channel 1. The same problem exists in channel 2 if channel 2 is the first to be turned up past 45 MA and then channel 1 is increased above 47 MA. A potentially hazardous situation associated with the use of the device is a sudden surge of stimulation on one of the output channels which could be experienced by users as an unpleasant shock situation. Potential risk identified is that the blade will not engage or retain screws for specified lot. Distributed product into Canada without license.
Center Drive Blade 2.0 A) 5 Panel Drugcheck NxStep Cups B) 10 Panel Drugcheck NxStep Cups C) Drugcheck NxStep Cups with Alcohol D) Drugcheck 2 Panel Dips E) 6 Panel Drugcheck NxScan Cups
Biomet Microfixation, Inc. Express Diagnostics International Inc.
2011-09-05 2011-09-05
2010-03-16 65974 2011-04-28 65559
Type III Type III
01-9047 A) 60505 B) 61020 C) 60500 A D) 30200 E) 70610
64980 A) 505031911, 505032311, 505022511 B) 020021411 C) A500 022111, A500040711 D) 200012411, 200020311 E) 610042111
Lightspeed VCT CT Scanner System
GE Medical Systems, LLC
2011-09-05
2011-08-10 65945
Type III
5212920-3XX
All
A) Allura XPER FD10/10-Main Unit B) Allura XPER FD20/10-Main Unit C) Allura XPER FD10 D) Allura XPER FD20 System Main Unit
Philips Medical Systems Nederland B.V.
2011-09-05
2011-08-02 65985
Type II
A) ALLURA XPER FD10/10 B) ALLURA XPER FD20/10 C) ALLURA XPER FD10 D) ALLURA XPER FD20
N/A
The ECG waveform trace may be missing in retro recon from scan data where the R-peak coincides with X-ray on signal resulting in captured data for an extra R-peak. As a result, the ECG waveform trace will not display and retrospective reconstruction is not possible for that series. Philips has identified a problem related to the hard disk firmware in allura XPER systems. The hard disk itself is working firmware has an incorrect incrementing smart counter. This might result in a very high "raw read error" count which will lead to a so called "smart trip" and subsequently will take the hard disk offline. Consequently the system might intermittently freeze. This can vary from several seconds up to one minute.
A) Drugcheck Dip Drug Tests B) AlcoCheck Breath Alcohol Screening C) Alcocheck Saliva Alcohol Screening D) DrugCheck Urine Alcohol Screening E) DrugCheck NxStep 14 Panel Cups F) Diagnostics Oraline Swab 4 Panel Drug Test G) QED Alcohol Saliva Test H) Drug Adulteration Test Strip A) Sensura Post-Op Sterile Ostomy Bag B) Sensura 1 pc. Drainable Sterile Ostomy Bag C) Assura/Alterna Post-Op Sterile Ostomy Bag Soothing Heat Cold Pack
Express Diagnostics International, Inc.
2011-09-05
2011-04-28 65563
Type III
A) 30100, 30110, 30111C, 30120, 30130, 30130C, 30140, 30140C, 30150, 30160, 30163, 30170, 31005 B) 40902, 40908 C) 40900 D) 40901, 40901C E) 61401 F) 40940 G) N/A H) D700-25 A) 19010, 19011 B) 19001 C) 12808, 12810 1200,1200B, 1200C, 5009A, 6001, 6005, 6006, 6008, 6012, 8009, 8012, 8012B, 8013, 8015, 8018, 8019, 8020, 8028, 8028B, 8028C, 8029, 8030, 8030B, 8030C, 8031, 8032, 8035, 8035P, 8040 MMT-643
A) All B) All C) All D) All E) All F) All G) All H) All A) 2785856, 2932899, 2785854 B) 2744872 C) 10#S - Contact Coloplast N/A
Distributed product into Canada without license. Products distributed not listed on the Class 2 license.
Coloplast A/S
2011-09-05
2011-07-25 66065
Type II
Failure of sterility testing. Sterility may be compromised in these products.
Warm Buddy Comp
2011-09-05
2011-07-15 66141
Type III
Uni-Solve Adhesive Remover Wipe
Medtronic MiniMed
2011-09-05
2011-07-28 66310
Type II
9K155
Coseal Surgical Sealant
Baxter Healthcare SA
2011-09-05
2011-07-28 66014
Type III
934071
HA090944, HA090950
The reason of the recall is for the exchange of the outer labels with the Medical Devices Bureau (MDB) approved labels along with the stick on label for the double sewn seam on the inner pack of each plush animal. Potential bacterial contamination of certain lots of Uni-Solve Adhesive Remover Wipes manufactured by the Triad Group for Smith & Nephew and Co.-packaged in the Medtronic Site Adhesive sample kit. The recall is being conducted as a precautionary measure due to Out of Specification (OOS) results observed at the 24 month time point (out of 24-month licensed shelf life to expiration) during a Coseal Stability study. The parameter that is OOS is an indicator of possible failure for the product to gel appropriately. All other stability requirements were met. There is a low frequency defect in the molding of the cuvettes that may result in cuvette ring and cuvette loader jams. Jams will cause downtime on the system. The molding defect can result in the cuvette flange or "wing" breaking, resulting in an error condition. No results are reported when jams occur, therefore patient results are not impacted. The intended use of the instrument is to bring the pole plug for Allofit / Allofit it hip cups in the correct position in order to fix the pole plug in the implant shell. In Lot 10524172 a discrepancy was found. The spring and washer to keep the pole plug in place are missing on the devices of this lot. Ethicon Endo-Surgery has initiated a global recall for specific production lots of Endopath ETS Compact Flex 45mm Articulating Linear Cutters because the possibility exists that damage to the blister pack may compromise the sterility of the device. McKesson received a report from one of their customers where images for one patient appeared in the study of another patient in their Horizon Medical Imaging (HMI) system. The incorrectly displayed study showed the images for patient a, but with name, Medical Record Number (MRN), procedure type and other database overlay information for patient B. Potential for IUD Insertion kit pouches not being sealed adequately. Spacelabs Healthcare has identified an issue with model 91367, 91369, 91370, 91387 & 91393 medical patient monitors equipped with the perioperative option (-D). One customer reported a safety concern over the inability to recognize the status of the monitor's audible alarms when the device has been left in the end case mode. Fluorscan Mini C-Arm Models Office Mate which could experience the following failure: The Flex Arm Connector to C-Arm can break and the C-Arm that is supported by the Flex Arm will fall down. Review of the design determined that the casting wall where a threaded hole is located for a set screw is marginal and there is a possibility that should there be an impact to that area, the wall could break causing the C-Arm to fall down. Two of the bolts that comprise part of the backrest hinge assembly-namely pivot stud and lock stud-may fail. The "rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system. If a patient study is renamed on one syngo imaging XS system and sent to another Syngo Imaging XS System, then the entire patient is renamed on the second system. This is a field corrective action on Premium Handling Belts produced before 2011. The issue is that the male part of the buckle can detach during transport or washing. Also, washing temperatures on the label were lower than temperatures recommended by the authorities. There was a notice from Prism Medical indicating a revised guidance on inspection and replacement for lift straps on TA and TP lifts. Per the notice received, during an inspection of a lifting tape on a lift that was being used in excess of 14 times a day at its full extent, excessive wear was noticed on the lift strap where the lift strap entered the tape gear. This part of the lift strap is not visible without lift strap removal. The lift strap in the ceiling lift was approximately 3 years old. There is a potential for the sterility and moisture barrier to be compromised.the use of the products with this condition may result in a potentially increased risk for infection and/or degradation of the reinforcement material. The PrepStain instrument automatically prepares and stains slides for cytology. Stains and rinses are applied to the sample in order to prepare the slide for cover slipping. A centrifuge is used as part of the sample preparation process. The centrifuge tube rack #2 is keyed incorrectly, not allowing proper alignment of the tube holders with the prepstain waste station. This could result in potential delays in processing of slides and thus create potential delays in reporting of patient results. Applying too much or tensile force to the head of the screw during insertion and fixation of the skull reference base may cause the screw head to deform or to shear off. In such case, the screw can no longer be removed the specified screwdriver or parts of the screw may remain inside the patient's skull bone. Hospira Inc. received customer's report of sparking, smoking, charring and shock when using the GemStar Docking Station. Hospira is recommending that all fluid ingress into the device is avoided.
Dimension Vista Cuvettes
2011-09-19
2011-08-09 66119
Type III
KS850
N/A
AlloFit MIS Setting Device for Pole Plug
Zimmer GMBH
2011-09-19
2011-08-12 66239
Type III
01.00502.007
10524172
Endopath ETS Compact Flex 45 Cutter
Ethicon Endo-Surgery, LLC
2011-09-19
2011-08-22 66387
Type II
CTS45
Horizon Medical Imaging (HMI)
McKesson Medical Imaging Company
2011-09-19
2011-06-13 64937
Type II
N/A
11.5, 11.5.1, 11.5.2, 11.6, 11.7, 11.8
IUD Insertion Kit A) Spacelabs Medical Patient Monitor 91370 B) Spacelabs Medical Patient Monitor 91359 C) Spacelabs Medical Patient Monitor 91387 Fluoroscan Mini C-Arm Office Mate
Gyn Disposables, Inc. Spacelabs Medical, Inc.
2011-09-19 2011-09-19
2011-07-29 66030 2011-08-07 66067
Type III Type II
935K A) 91370 B) 91369 C) 91387 50600
61034034 A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer S/N: 02-0204-01, S/N: 02-0304-01, S/N: 020903-01, S/N: 02-0899-13
Hologic, Inc.
2011-09-19
2011-08-22 66535
Type II
A) TiLite ZR Series 2 Wheelchair B) TiLite ZRA Series 2 Wheelchair Syngo Imaging XS VA70A
Tisport, LLC.
2011-09-19
2011-07-28 66405
Type III
A) Z2FS2 B) Z2FS1 10496279
A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer N/A
Siemens AG
2011-09-19
2011-08-03 66198
Type II
Etac Premium Handling Belt
Etac AB
2011-09-19
2011-08-18 66367
Type II
255303-Premium Handling Belt, 255304-Premium Handling Belt, 255305-Premium Handling Belt A) 313100-TA Manual Traverse, 313150-TA Power Traverse, 313175-TA Power Traverse, 313177-TA Power Transtrip B) 303000-Transportable Lift, 303030- Transpoint TP Lift
N/A
A) Transactive Lifts (TA) B) Transportable Lifts (TP)
Waverley Glen Systems - Division of Prism Medical Ltd.
2011-09-19
2011-08-16 66368
Type II
A) S/N: TA200000 - TA600279 B) S/N: TP10000 - TP106460
A) Duet TRS Universal Straight Sulu B) Duet TRS Articulating Sulu Centrifuge Tube Racks for Prestain
Covidien LLC
2011-09-19
2011-08-18 66450
Type II
A) Duet4535, Duet4548, Duet6035, Duet6048 B) Duet4535A, Duet4548A, Duet6035A, Duet6048A 799-13001-02
A) >10, Please Contact Manufacturer B) >10, Please Contact Manufacturer 236
TriPath Imaging, Inc.
2011-09-19
2011-05-27 65792
Type III
BrainLAB Skull Reference Base
BrainLAB AG
2011-09-19
2011-08-08 65973
Type II
52120D, 52121B, 52129, 52129A
N/A
GemStar Docking Station
Hospira Inc.
2011-09-19
2011-08-01 66150
Type II
13075
>10, Please Contact Manufacturer
Syngo Plaza
Siemens AG
2011-09-19
2011-08-08 66199
Type II
IVK 105 92 457
S/N 100011
Electa Synergy XVI (X-ray Volume Imaging System Lina Loop Syngo Dynamics
Elekta Limited Lina Medical APS Siemens Medical Solutions USA, Inc.
2011-09-19 2011-09-19 2011-09-19
2011-03-09 66455 2011-01-01 66458 2011-08-25 66598
N/A EL-160-8, EL-200-4, EL-200-8 10090480
Version 4.5.0 7282, 7415, 8283, 8284, 8285, 8292, 8393, 8395, 8411, 8442, 8453, 9081, 9131, 9231 S/N 92241
If a patient study is renamed on one Syngo.Plaza or Syngo Imaging XS System and sent to another Syngo.Plaza or Syngo Imaging XS System, then the entire patient is renamed on the second system. This can cause an unintended merge of patients. Incorrect Monitor Units (MU) are recorded after "confirm settings" or "unconfirm settings" is pressed. There is a potential for the device Lina Loop to break during the operating procedure. This advisory is specific to customers who have upgraded to Syngo Dynamics Version 9.0 with Legacy reports generated by Syngo Dynamics Systems Version 3.x or earlier. If a Legacy report is opened in Syngo Dynamics 9.0 Web Portal, the report may be deleted and replaced with a new report from the 9.0 reporting system or with a blank report. Customer safety advisory notice to inform customer of an unitended behavior when using Syngo Imaging XS, Versions VA70A and VA70B client/server installations. Loading images / series from patient browser using the thumbnails can cause an unintended deletion of images / series. There have been customer inquiries for discordant results on QC and patients following calibration with Lot LAD045. Internal testing has confirmed a 30% positive shift between the 99th percentile (0.056 ng/ml) and 0.1 ng/ml. Operations has confirmed the accuracy of subsequent Lots of calibrator. Cell-Dyn 3700 customers had reported occurrences of visible fire and smoke from the analyzer. In addition, a Cell-Dyn 3200 customer reported smoke from the analyzer. Returned power supply units were analyzed and were identified to contain the incorrect fuse for the electrical configuration at the customer site.
Syngo Imaging SX
Siemens AG
2011-09-19
2011-08-26 66599
Type II
10496279
S/N 1225, S/N 2006, S/N 2163
Dimension EXL System - (Troponin) TNI Assay
2011-09-19
2011-08-31 66699
Type III
RC621
1AD045
A) Cell-Dyn 3500 Haematology System - CS Analyzer B) Cell-Dyn 3500 Haematology System - Refurbished CS Analyzer C) Cell-Dyn 3500 Haematology System - Sl Analyzer D) Cell-Dyn 3500 Haematology System - Refurbished Sl Analyzer A) Cell-Dyn 3700 Haematology System -Sl Analyser B) Cell-Dyn Ruby Haematology System - Analyzer C) Cell-Dyn 3500 Haematology System A) Instatrak 3000 - Sensor Cables B) Instatrak 3500 - Sensor Cables C) Instatrak 3500 Plus - Sensor Cables
Abbott Laboratories Diagnostic Division
2011-09-19
2011-10-22 56461
Type III
A) 91340-01 B) 91340-03 C) 91350-01 D) 91350-03
A) All B) All C) All D) All
2011-09-19
201103-24 62481
Type III
A) 02H31-01 B) 08H67-01 C) 91350-03 A) 1001989, 1002008 B) 1001989, 1001990, 1002008, 1004069 C) 1007907-NAV, 1007914-NAV
A) 20576AK B) 35705BG C) 32159P96 A) All B) All C) All
The shear valve assembly was rejected during testing in manufacturing due to a "shear valve position" fault or "RBC diluent syringe overpressure" sim. It was noticed that the nylon washer (pn 2808159) had an outer diameter which was OOS (undersized) causing it to become caught within the adjacent drive plate's opening. The customer labelling for transmitter sensor cables and receiver sensor cables states that the cables can be sterilized with the Sterrad Sterilization System. At the initial release of these products, the only sterrad method was the 100S model. Sterrad has since introduced the 100NX and NX models. The transmitter sensor cable and receiver sensor cable have been validated for sterilization in the sterrad 100S Sterilizer and Ethylene Oxide (ETO) Sterilizers only. These products have not been validated for use in any other Sterrad Sterilizer. GE OEC Medical Systems Inc. internal testing has shown the high concentration of hydrogen peroxide used in the Sterrad 100NX Sterilizer is not compatible with some of the materials used in the transmitter sensor cable, which may result in the degradation of the material. This could lead to a sterilization issue. Testing shows that the receivers are not affected by the change in sterilization.
GE OEC Medical Systems Inc.
2011-10-03
2011-04-05 62579
Type III
Warmair Model 134
Cincinnati Sub-Zero Products
2011-10-03
2011-06-09 65793
Type II
134
963-1340100 to 004-1341426
Segmented Cylinder Set
Varian Medical Systems Inc.
2011-10-03
2011-07-13 66153
Type II
GM11004150
> 10 Serial Numbers Contact Manufacturer
One of the connectors attached to the Warmair 134 device's printed circuit board can overheat. May result in damage to the device's external case and/or melting of some of the internal components. In the previous recall (55250), the blocking washer on the flexible probe (GM11002420) may shift and users are not to use a flexible probe with an unstable or shifted blocking washer due to potential for treatment error. This update notice supplements and modifies the previous instructions that you may continue to use the original design flexible probe with blocking washer and old design guiding tube. Here, users are instructed to stop using these older products (GM11002420) flexible applicabtor probe with blocking washer at 234 mm (Old design) GM11005170 guiding tube for segmented cylinders (Old design). This update notice request requires that users return these original design products to varian brachytherapy for replacement with the updated designs for them free of charge. 1) Possible impact of significant vibration or jarring to Omnifuse pumps: Due to sensitivities of the precision accuracy detection mechanisms within Omnifuse pumps, certain levels of vibration or jarring during transport can induce a system fault code. 2) Affect on the Totaliser display after resetting the pump to clear a system fault: If a system fault code occurs during an infusion and the pump is reset, the Totaliser display will not include the most recent infusion data. Ortho Clinical Diagnostics has received complaints of broken vials during shipment for some Ortho blood products. Studies show that vial to vial contact during the shipping process is one of the key contributors to this vial breakage. / Ortho-Clinical Diagnostics a reu une plainte selon laquelle des fioles ont t casses pendant le transport de certains produits base de sang. Des tudes montrent que le problme rsulte principalement dun choc entre des fioles durant la livraison des produits.
A) Omnifuse Syringe Pumps B) Omnifuse PCA Syringe Pump
Smiths Medical ASD. Inc.
2011-10-03
2011-08-03 66188
Type II
A) 0158-0710, 0159-0710 B) 0153-0710, 0153-0711
A) All B) All
A) Reagent Red Blood Cells SELECTOGEN Ortho-Clinical Diagnostics Inc. B) Reagent Red Blood Cells AFFIRMAGEN C) Reagent Red Blood Cells SURGISCREEN D) ORTHO Confidence System E) Blood Grouping Reagent Anti-D (Murine Monoclonal Blend) BioClone for Slide F) Reagent Red Blood Cells 0.8% SELECTOGEN G) Reagent Red Blood Cells 0.8% SURGISCREEN H) Blood Grouping Reagent Anti-A (Murine Monoclonal Blend) BioClone for Slide I) Blood Grouping Reagent Anti-B (Murine Monoclonal Blend) BioClone for Slide J) Blood Grouping Reagent Anti-A,B (Murine Monoclonal Blend) BioClone for Slide K) Reagent Red Blood Cells 0.8% AFFIRMAGEN
2011-10-03
2011-08-19 66317
Type III
A) 79610 B) 719210 C) 719100 D) 6902096 E) 6901939 F) 6902315 G) 6902316 H) 711228 I) 711328 J) 711528 K) 71901
A) S531 B) A282 C) 3SS407, 3SS408 D) CNF790, CNF786 E) DB285A1, DB286A1, DB287A F) VS466 G) VSS399 H) BAA587AX, BAA588AX, BAA589AX I) BBB778AX, BBB779AX, BBB780AX, BBB781AX J) ABB692AX, ABB693AX K) 8A694, 8A704
28 mm & 30 mm AcuTwist Acutrak Compression Screws
Acumed Inc.
2011-10-03
2011-08-03 66546
Type III
N/A
AI-0028-S, Lot 248000, AI-0030-S, Lot 250212
Product is labeled as AI-0030-S, Batch 25012 but an AI-0028-S, Batch 248000 is inside the packaging. Product is labeled as AI-0028-S, Batch 248000 but an AI-0030-S, batch 250212 is inside the packaging. Based on Acumed's health hazard evaluation, there is no additional risk to health to the end user of this product. Acumed received a customer complaint on 7/22/2011.
A) ViziShot Single Use Aspiration Needles B) ViziShot Single Use Aspiration Needles BD Retic-COUNT Reticulocyte Reagent System A) Sta-System Control N+P B) Sta-System Control N+P Architect System - Alkaline Phosphatase Assay
Olympus Medical Sysrtems Corp.
2011-10-03
2011-09-06 66569
Type III
A) NA-201SX-4022 B) NA-201SX-4021 349204 A) 00678 B) 00678 7D55-21, 7D55-31
A) All B) All 3847 A) 106775 B) 106775 62474UN10, 71628UN10, 08145UN11
Becton, Dickinson and Company BD Biosciences Diagnostica Stago SAS Abbott Laboratories Diagnostic Division
2011-10-03 2011-10-03 2010-10-03
2011-08-15 66631 2011-08-18 66632 2011-08-30 66698
Mammot Inspiration
Siemens AG
2010-10-03
2011-08-31 66721
Type I
10140000
N/A
Olympus is aware of complaints in which users are able to wipe metal particles from the stylet of the ViziShot's needle. The metal particles may contaminate the specimens obtained during fine needle aspiration. Storage condition printed on shipping container state 2-25 C and should state 2-8 C. the storage condition printed on the bottled product is correct (2-8 C). Diagnostica Stago was aware that STA System Control N+P Factor VIII results were not within the assigned acceptance range. Alkaline phosphatase has been reported to contain visible mold inside multiple R2 cartridges. In-house visible observation of customer returns and in-house R2 reagents found visible matter inside multiple R2 cartridges. In-house testing was performed, the lot failed to calibrate/generate results and failed to meet the following specifications: microbial contamination of less than 30 CFU, the reagent being free of foreign matter, and performance criteria by a failure to calibrate or generate results with an active calibration. Lowering the swivel arm with "object table" while an operator's or a patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. The movement of the swivel arm may also cause an injury. During a biopsy examination the swivel arm of the system might be tilted to somewhere between +15 and -15 degrees and when starting the examination to acquire stereo images, the swivel arm may automatically move between +15 to -15 degrees. This movement may cause body parts to be pinched or otherwise injured, particularly with seated or recumbent patients.
Vitek 2 Yeast Identification Card (YST) Medtronic SynchroMed II Implantable Programmable Drug Pump Therakos Cellex Photopheresis System
bioMrieux Inc. Medtronic Inc.
2011-10-03 2011-10-03
2011-09-02 66785 2011-07-05 66803
Type II Type II
N/A 8637-20, 8637-40
243210940 Not Lot Specific, Contact Manufacturer
Therakos Inc.
2011-10-03
2011-09-02 66808
Type II
Therakos Cellex
40233, 40138, 40223, 40234
A) VITROS ECi/ECiQ Immunodiagnostic Systems Software V Ortho-Clinical Diagnostics Inc. 3.8 & below / VITROS Immunodiagnostic Products Total betahCG II Reagent Packs Lots 0484 & Above B) VITROS ECi/ECiQ Immunodiagnostic Systems Software V 3.8 & below/VITROS Immunodiagnostic Products Total betahCG II Reagent Packs Lots 0484 & Above
2011-10-03
2011-08-25 66825
Type II
A) 8633893 B) 1922814
A) Lots 0484 and above B) Lots 0484 and above
There is a possibility of false positive results on QC strains for a specific lot of Vitek 2 Yeast identification cards. This field action is to provide an update to important safety information and patient management recommendations related to the potential for reduced battery performance in a small percentage of SynchroMed II pumps. Of 18,000 treatments performed to date, Therakos received three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Cellex Photopheresis system. The investigation suggests that heat generated in the centrifuge chamber may be responsible for red cell changes that may rarely result in post reinfusion hemolysis or hemoglobinuria. The purpose of the recall notification is to provide customers with recommended actions intended to reduce heat build-up in the centrifuge chamber of the Cellex system. There is a software issue that may affect results from diluted samples run on the Vitros ECI Immunodiagnostic System tested with the Vitros Immunodiagnostics products Total BetaHCG II Reagent pack. OCD has received complaints of observed results from diluted samples that were reported as <2.39 Miu/ml (iu/l) instead of the correct 'no result', which is accompanied by an invalid dilution (ID) code. The diluted results were inconsistent with results from the neat (Undiluted) sample, which was within the measuring range of 2.3915,000 miu/ml.
Endodontic Reducer Contra Angle Handpiece Dimension EXL System (Troponin) TNI Assay Micrusphere Xl 10 Microcoil System
Anthogyr Siemens Healthcare Diagnostics Inc. Micrus Endovascular Corporation
2011-10-03 2011-10-03 2011-10-03
2011-08-24 66901 2011-09-02 66908 2011-09-09 66909
815-9008, 815-9010 RF621 SSR 100514-20
All Lots ED2098, EA2111, FB2134, ED2147 G10559, G10560
Product was not licenced until Sept 8, 2011. There have been customer complaints for low recovery of QC and patient samples with specified lots. Low patient results are due to troubleshooting following low recovery of QC. A typographical error may exist on the package label and peel-off stickers that are placed on the packaging of certain Micrusphere XL 10 Microcoil systems. The product catalog number on the package does not match the catalog number that was ordered. However, the product inside the package is correct. Customers who ordered SSR 100514-20 (Micrusphere XL 10, 5mm x 14cm) received product that was labeled SSR 100514-10 (Micrusphere XL 10, 5mm x 14cm). The -10 catalog number extension does not exist in the Micrus product catalog. A customer reported an unexpected negative result in an Antibody Assay on the Galileo Echo. Through customer feedback and field service experience, steris has learned that Amsco VPro 1 and V-Pro 1 Plus low temperature sterilization systems users may experience premature wear of the vacuum pump and filtering components. Users may also experience incomplete aeration of the device's chamber following a failed leak test. A significant volume of alcohol was reported to have leaked from Symphony Automated Staining System onto the floor area surrounding the instrument which was identified as potential slip and fall/or flammability. Zimmer GMBH is initiating a recall by issuing a revised instructions for use (IFU) for the Biolox Option Ceramic Femoral Head system, sizes 28mm to 40mm. Zimmer determined that the current information as described in the IFU and in the design rational document was confusing. The system offers the option to treat primary and revision cases. In hip revision surgery, the original stem could remain in situ. For this specific scenario, the Biolox Option IFU and the Design Rationale document related to the heads, have been revised to improve the definition for the level of allowed damage for the stem taper.
Galileo Echo Instrument
Immucor Inc.
2011-10-03 2011-10-03
2011-09-09 66967 2011-09-14 66991
Type I Type II
87000 A) VP10001101, VP10002101, VP10002102 B) VP20002101
All A) S/N: 033640901, 030830903, 030400926, 030300909, 033650804, 032740804, 032750832, 032820802, 032460810 B) S/N: 030701116 P/N 06114270001, P/N 900-SYM3, S/N 390000 and higher > 10 Lots, Contact the Manufacturer
A) Amsco V-Pro 1 Low Temperature Sterilization System Steris Mexico B) Amsco V-Pro 1 Plus Low Temperature Sterilization System
Symphony Automated Staining System
Ventana Medical Systems Inc.
2011-10-03
2011-09-13 67043
Type III
N/A
Biolox Option Ceramic Femoral Heads
Zimmer GMBH
2011-10-03
2011-09-15 67060
Type II
00877702801, 00877702802, 00877702803, 00877702804, 00877703201, 00877703202, 00877703203, 00877703204, 00877703601, 00877703602, 00877703603, 00877703604, 00877704001, 00877704002, 00877704003, 00877704004
A) Vaginal-Applicator Set B) Stump Applicator Set
2011-10-17
2011-07-13 66008
Type II
A) GM11002560 B) GM11002560
A) >10 Numbers Contact Manufacturer / B) >10 Numbers Contact Manufacturer /
In previous recall (HC# 55250), this addressed the Flexible Applicator Probes that can shrink by up to 2mm after autoclaving. It has been determined that a portion of the shipped inventory of Flexible Applicator Probes was not heat annealed. This recall supplements previous instructions by requring users to stop using any Flexible Applicator Probes that may still be in inventory with lot numbers D01 to H14 inclusive. These applicator probes are to be returned to Varian Brachytherapy for replacement with Lots after H14. The purpose of this field action is to inform customers of issues related to the Directions for Use (DFU) provided with the pressure display box and pressure display set. These issues are accuracy in the negative pressure range and length of use. Medtronic has become aware that the pressure display box may not always accurately display readings. The negative pressure inaccuracy is relevant in applications involving "high vacuum" settings. These applications would be vacuum assisted venous drainage (VAVD), and port access/mini sternotomy procedures. When used for an extended period (>24 hours) the positive pressure display may drift due to air leakage in the system.
A) DLP Pressure Display with Remote Alarm Box B) DLP Pressure Display Set
Medtronic Inc.
2011-10-17
2011-09-12 66935
Type III
A) 60000, 63000, 64000, 66000 B) 61000, 61006, 62000, 62006
A) >10 Numbers Contact Manufacturer / B) >100 Numbers Contact Manufacturer /
A) Advia 120 Hematology System - Analyzer Siemens Healthcare Diagnostics Inc. B) Advia 2120i Analyzer with Autosampler with Auto Waste C) Advia 2120i Analyzer with Autosampler with Manual Waste D) Advia 2120i Analyzer Without Autosampler with Manual Waste E) Advia 2120 with Dual Aspiration Autosampler F) Advia 2120 Without Autosampler G) Advia 2120 with Autosampler
2011-10-17
2011-09-14 67005
Type III
A) 10310973, 10317457 B) 10284942, 10361798 C) 10361802, 10361803 D) 10361793, 10361794 E) 10313419 F) 10315687 G) 10316162
A) N/A B) N/A C) N/A D) N/A E) N/A F) N/A G) N/A
Customer complaint received that during troubleshooting a syringe filled with EZ Kleen was connected to the Perox 2 Reagent tubing. The EZ Kleen sprayed on the operator's forehead after the syringe plunger causing the Tygon tubing to disconnect at the check valve.
T-Pal Spacer Brochure
Synthes (Canada) Inc.
2011-10-17
2011-09-13 67098
Type III
08.812.007, 08.812.008, 08.812.009, 08.812.010, 08.812.011, 08.812.012, 08.812.013, 08.812.014, 08.812.015, 08.812.016, 08.812.017, 08.812.207, 08.812.208, 08.812.209, 08.812.210, 08.812.211, 08.812.212, 08.812.213, 08.812.214, 08.812.215, 08.812.216, 08.812.217
N/A
LifeCycle for Prenatal Screening A) SonoSite M-Turbo Ultrasound System B) MicroMaxx Ultrasound System, C3.4.3 ABT
Wallac OY SonoSite Inc.
2011-10-17 2011-10-17
2011-08-12 66240 2011-09-02 66474
Type II Type II
5002-0020 A) P08189 B) P08840
v.3.0, v.3.1, v.3.2 A) >10 Numbers Contact Manufacturer / B) WK03LN, WK03QQ, WK037Q, WK02T6
A) Eius Knee System - Femoral Components B) Eius Knee System - Tibial Components
Howmedica Osteonics Corporation
2011-10-17
2011-09-01 66890
Type II
A) 6636-2-001, 6636-2-002, 6636-2-003, 6636-2-004, 6636-2-005, 6636-2-011, A) All 6636-2-012, 6636-2-013, 6636-2-014, 6636-2-015 B) All B) 6636-2-308, 6636-2-309, 6636-2-310, 6636-2-312, 6636-2-318, 6636-2-319, 6636-2-320, 6636-2-322, 6636-2-408, 6636-2-409, 6636-2-410, 6636-2-412, 66362-418, 6636-2-419, 6636-2-420, 6636-2-422, 6636-2-508, 6636-2-509, 6636-2-510, 6636-2-512, 6636-2-518, 6636-2-519, 6636-2-520, 6636-2-522, 6636-2-608, 66362-609, 6636-2-610, 6636-2-612, 6636-2-618, 6636-2-619, 6636-2-620, 6636-2-622, 6636-2-708, 6636-2-709, 6636-2-710, 6636-2-712, 6636-2-718, 6636-2-719, 66362-720, 6636-2-722 602290 RESF1061, RESI0209, RESK0806, RETA0584
Synthes (Canada), Ltd. Is initiating a medical device labelling recall related to the Synthes TPal Spacer System, specifically regarding the use of the T-Pal Spacer with Allograft material. This action has been initiated following a regulatory review of all labelling and promotional materials associated with the T-P-pal Spacer System which is currently only indicated for use with Autograft. There have been no additional risks to the patient identified, associated with the use of the T-Pal Spacer System with Allograft material. Limitations of repeated measures testing in cross-trimester screening. During the development process on a research product platform, Sonosite discovered a data (Ratio) display anomaly for a specific calculation within the extended OB/GYN Calculation software package. The anomaly exists on the noted M-Turbo and Micromaxx Ultrasound Systems when enabled with the extended OB?GYN Calculation package. While performing a systolic/diastolic (S/D) ratio measurement, if the systolic caliper is repositioned after setting the diastolic cursor, the S/D ratio shown at the bottom of the display screen is not updated to reflect the new ratio value (but the correct S/D ratio is printed on patient reports). Stryker was aware that the revision rates associated with the Eius Knee System were higher than other similar devices.
Bardport Titanium Implanted Port
Bard Access Systems Inc.
2011-10-17
2011-09-23 67235
Type III
There is a labeling discrepancy specific to listed lot numbers of Bardport Titanium Implanted Port (PC 0602290). The end flap label indicates a different product description as compared to the main label. The main label identifies the port as a "Titanium Implanted Port", while the end flap identifies the port as a "Titanium Low-Profile Implanted Port". The product inside the kit is a regular port and not a low-profile port. A complaint with a system in which the inability to perform rotational angiography occurred twice. The cause was traced to a sensor in the magnus column as a result of an incorrect signal from this sensor, all high-speed movements of the C-Arc were blocked. An incorrect signal can have an effect, during high-speed applications of the allura system (3DRA, Xperct, Xperswing). If the fault occurs during daily xperct calibration, this function will not be available. If the fault occurs prior to or during a high-speed application, the acquisition cannot be set-up and the movement function of both the C-Arc and the magnus operating table are locked. The described fault does not affect other functions of the system. The sodium content of some elution buffers could be altered, which would cause calibration failures. Bayer has issued a global stop on new shipments of the 5-, 10-, and 25-count vials of Contour, Contour Link, and Contour TS blood glucose test strips out of an abundance of caution to address a packaging issue discovered during routine internal quality testing. It was identified that under certain conditions, some test strips in some 5-, 10-, or 25-count vials can produce a low bias reading during blood glucose testing. Implant can experience intermittent behaviour that leads to safe shut down and cessation of function. Failed units require explant and replacement. Synthes Canada is initiating a medical device labelling recall related to the Synthes Zero-P instrument and implants technique guide, document #J8566, revision C and previous that references the use of Peek-CR as a cervical interbody spacer. Peek-CR is not currently indicated for use as cervical interbody spacer. There have been no additional risks to the patient identified that are associated with the use of the Peek-CR as a cervical interbody spacer. Sodium content of certain elution buffer could be altered, which would result in calibration failures. The boom arm of the Synchrony Camera Array mounting assembly could unexpectedly detach from the mounting pole during manipulation by the user. A user reported the standard treatment couch table top had partially detached from the support column and descended to the floor. There was no patient involved. No serious injury was reported by the user. The part number on the product labels for the disposable Adult Manual Resuscitators substitution is incorrect. The products were sent out as OL-500100-00 and should have been labeled OL-500102-00 and/or 500101-00. This was brought to Bomimed's attention september 12, 2011. Pupil Centroid Shift Compensation is not functioning as intended in the Iris Registration (IR) software, versions 5.00 through 5.30. As a result, the center of the ablation pattern may not be optimally aligned. This may, in some cases, result in visual disturbances or reduced best corrected visual acuity. The mini clamps used on the Transducer Protector line of the Venous line are manufactured from materials not suitable for gamma sterilization causing them to crack and break. Nipro Medical corporation received two complaints from Baxter Corporation Canada regarding the defective clamps. Internal testing has confirmed low recovery of QC and patient samples. Use of one of these lots may show a downward shift in QC and patient results. This decrease may cause a sample that is slightly above the 99th percentile (0.056 ng/ml) of a reference population to read below this value. At higher values of TNI, samples will remain positive and the bias is not clinically significant.
Magnus Hybrid operating table columns
Maquet Gmbh & Co. KG
2011-10-17
2011-09-08 66892
Type II
1180.01A1
23
Variant II B-Thalassemia Short Program Reorder Pack Contour Blood Glucose Test Strips
Bio-Rad Laboratories Diagnostics Group Bayer Healthcare LLC Subsidiary of Bayer Corporation
2011-10-17 2011-10-17
2011-09-19 67167 2011-09-22 67227
Type III Type III
2702154 9546B, 9546C, 9586, 9586A
2702154 >10 Numbers Contact Manufacturer
A) Nucleus CI500 Cochlear Implant Series B) Nucleus CI500 Cochlear Implant Series A) Zero-P Technique Guide - Parallel Sterile B) Zero-P Technique Guide - Lordotic Sterile C) Zero-P Technique Guide - Convex Sterile
Cochlear Limited
2011-10-17
2011-09-19 67074
Type II
A) Z209051 B) Z110048 A) 04.617.110S, 04.617.111S, 04.617.112S, 04.617.115S, 04.617.116S, 04.617.117S, 04.617.118S, 04.617.119S B) 04.617.120S, 04.617.121S, 04.617.122S, 04.617.125S, 04.617.126S, 04.617.127S, 04.617.128S, 04.617.129S C) 04.617.130S, 04.617.131S, 04.617.132S, 04.617.135S, 04.617.136S, 04.617.137S, 04.617.138S, 04.617.139S N/A 026429, 026430, 028185, 028186 N/A
A) >10 Numbers Contact Manufacturer B) >10 Numbers Contact Manufacturer A) All B) All C) All
Synthes (Canada) Inc.
2011-10-17
2011-09-13 67099
Type III
D-10 Hemoglobin A1C Program Reorder Pack Synchrony Respiratory Tracking System CyberKnife Standard Treatment Couch
Bio-Rad Laboratories Diagnostics Group Accuray Inc. Accuray Inc.
2011-10-17 2011-10-17 2011-10-17
2011-09-19 67173 2011-09-12 67213 2011-09-16 67217
20010946, 20011075, 20011077, 20011079, 20011081 C0231, C0202, C0238 C0231, C0202, C0238
Adult Disposable Manual Resuscitator
BOMImed Inc.
2011-10-17
2011-09-14 67267
Type II
OL-500101-00, OL-500102-00
072111, 082411, 082511, 082611, 082911, 090711
VISX Excimer Laser System - Star S4 IR
AMO Manufacturing USA, LLC
2011-10-17
2011-07-22 66069
Type II
Star S4 IR
>10 Numbers Contact Manufacturer
Nipro Bloodline
Nipro Corporation
2011-10-17
2011-09-07 66987
Type II
A230TR/V810TR
10F16, 10F18, 10F19
Dimesion EXL System-(Troponin) TNI Assay
2011-10-17
2011-09-02 67201
Type II
RF621
ED2098, EA2111, FB2134, ED2147
Brightview XCT Imaging System-Tilt System
Philips Medical Systems (Cleveland) Inc.
2011-10-17
2011-09-21 67203
Type II
453560462131, 453560749161
N/A
A) On-Board Imager B) Clinac IX High Energy Linear Accelerator C) Trilogy High Energy Linear Accelerator D) Clinac 21EX High Energy Linear Accelerator
2011-10-17
2011-05-24 65613
Type II
A) H080194, H080268, H080213, H080217, H080059, H082103, H080060, H080286, H080220 B) H291178, H291016, H293307, H291021, H291194 C) H291166, H291172 D) H272370, H272407 N/A
Philips will be providing a software upgrade to Brightview XCT system customers to improve the functionality of the device and correct several issues that either have no identified hazards or have been determined to have minimal risk. An anomaly has been identified with the High - Energy Clinac Gantry Center Throat Cover where the cover may lean toward isocenter far enough to strike a patient. This issue is limited to center throat covers on high energy clinacs (H14, H27, H29) with V1.0 of the Obi KV Imaging System. These covers are associated with the Obi Air-Cooled KV X-Ray tube. Other center throat covers use a different design.
Syngo Dynamics
Siemens Medical Solutions USA Inc.
2011-10-17
2011-09-13 67285
Type III
100-90-480
If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to the following unexpected behaviour: 1) Any changes made to the report since the last saved version will not be saved. 2) Marking the study as read (clicking the verify button) might leave the study in an unread state or might mark the study as read but leave the report with a "preliminary" watermark displayed. Drape is not unwinding from the roll, making the product unusable. A software error in the Juan/Thermo-Fisher C4i Centrifuge sold with the Prepstain system causes the centrifuge to display an inaccurate G force or RPM reading during operation. In each case that has been investigated, the centrifuge was operating properly, but the display was showing a value that was lower than the true value. Specific lots potentially have decreased tensile strength of the Distal Tip when tested at three year shelf-life. Two year shelf-life dated product is not affected.
Steri-Drape Roll Prep Drape Juan/Thermo-Fisher Centrifuge Model C4i
3M Health Care Tripath Imaging, Inc.
2011-10-17 2011-10-17
2011-09-26 67371 2011-07-05 66857
Type III Type III
1000NSR 799-13000-00, 799-14000-00
2013-O3 AC, 2013-O3 AD, 2016-03 AY, 201603 BA All
A) Cruiser Hydro Coronary and Peripheral Artery Guide Wire Biotronik AG HF B) Cruiser Hydro Coronary and Peripheral Artery Guide Wire F C) Cruiser Hydro Coronary and Peripheral Artery Guide Wire M D) Cruiser Hydro Coronary and Peripheral Artery Guide Wire ES-HF E) Cruiser Hydro Coronary and Peripheral Artery Guide Wire ES-F
2011-10-17
2011-09-07 66925
Type II
A) 351455 B) 351456 C) 351457 D) 351458 E) 351459
A) >10 Numbers Contact Manufacturer / B) >10 Numbers Contact Manufacturer / C) 08099006, 10099007, 10099008, 01109001, 01109002 D) >10 Numbers Contact Manufacturer / E) 9099001, 10099001, 10099003, 02109003
Slidex Staph Plus Panocell-10
bioMrieux SA Immucor Inc.
2011-10-17 2011-10-17
2011-09-09 66969 2011-09-19 67149
Type II Type III
73115, 73116 3032
1102104106, 1012103761, 1011103665, 1012103706 33142
Bartels Clostridium Difficile Antioxin Berichrom Pai
Mardx Diagnostics Inc., a Trinity Biotech Company Siemens Healthcare Diagnostics Products GMBH
2011-10-17 2011-10-17
2011-08-31 67376 2011-09-26 67378
Type III Type III
B1029-70C OWOA15
K-949 541572
Level Sensor II Pads, Gel Included A) NCS Strep A Twist Rapid Test Device B) NCS Strep A Rapid Test Device
Terumo Cardiovascular Systems Corp. Nova Century Scientific Inc.
2011-10-31 2011-10-31
2011-09-30 67277 2011-09-21 67280
Type II Type II
195240 A) NCS-502T B) NCS-502
> 10 Numbers, Contact the Manufacturer A) 0060010, 0060032, 0100050, 8100037, 8100040, 9010062, 9080038 B) 0060011, 1010001, 1030052, 1040066, 1070036, 8110066, 9010101, 9030062, 9030135, 0960069 00428, 00350, 00409
Philips NM3 Monitor
Respironics Novametrix, LLC
2011-10-31
2011-08-29 67464
Type II
1051674
A) coDiagnostiX station B) coDiagnostiX PPP C) Online Upgrade coDiagnostiX Station D) coDiagnostiX coDoctor Panocell-10
Institut Straumann AG
2011-10-31
2011-08-02 66015
Type II
A) 019.0372 B) 019.0370 C) 019.0386 D) 019.0387 3032
A) N/A B) N/A C) N/A D) N/A 33142
A problem with R1 Reagent specificity (Anti-Staphylococcus Aureus Latex) could lead to false positive results with Staphylococcus Non-Aureus strains. The following antigens are incorrectly listed as negative on the supplemental unconfirmed typings for Cell 5 (Donor E841): I, GE, TJA, VEL, YTA, DIB, and U. Cell 5 is positive for the I, GE, TJA, VEL, YTA, DIB, and U antigens. Quality Control Department has detected the presence of a mold contaminant in the antitoxin reagent. Specified lot can result in clinical significant lower Pai values compared to previous lots. High Pai concentrations (>10 u/ml) might be underestimated and in the low reference range patient results might be found even below the reference range. Pads detaching from the surface of the venous reservoir. Pads exhibited reduced adhesion to the reservoir surface. Through testing it was determined that this product may have an elevated incidence of false positive results. A false positive test result could lead to the administration of antibiotics that are unnecessary. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. The root cause is still under investigation. Some units exhibit a mechanical problem that could result in the display of incorrect tidal and minute volumes. Inaccurate data could lead to an incorrect treatment for mechanically ventilated patients. This can lead to high PCO2 and low PH level in the patient. If user changes the implant length after the planning stage has been completed with the 2.8mm slkeeve, the software does not recognize the change.
Immucor Inc.
2011-10-31
2011-09-19 67149
Type III
A) Access System - Total T4 Assay B) Unicel Dxi 600 Access Immunoassay System - Total T4 Assay C) Unicel Dxi 800 Access Immunoassay System - Total T4 Assay Entroy Pool Lift
2011-10-31
2011-03-07 62307
Type II
A) 33800 B) 33800 C) 33800
A) All Reagent Packs B) All Reagent Packs C) All Reagent Packs
The following antigens are incorrectly listed as negative on the supplemental unconfirmed typings for Cell 5 (Donor E841): I, GE, TJA, VEL, YTA, DIB, and U. Cell 5 is positive for the I, GE, TJA, VEL, YTA, DIB, and U antigens. The concentration of Total T4 in samples from pregnant women is erroneously low when measured using the access Total T4 assay.
Arjo Hospital Equipment AB
2011-10-31
2011-07-14 66513
Type II
GAB1000-01-US, GAB1000-01-XX, GAB1000-11-XX, GAC100X N/A
N/A
Encore100 Toric Soft Contact Lens
CooperVison Inc.
2011-10-31
2011-08-19 66568
Type II
> 1000 Numbers, Contact Manufacturer,
A design flaw in the Actuator suspension may allow booms to lower quickly, un-commanded to the bottom of its stroke. The defect renders the lift inoperable and my result in serious injury. There is unintended presence of a residue on lenses from certain lots of Encore100 Toric contact lenses. The company received complaints of temporary hazy or blurry vision, and discomfort, most likely caused by transient or reversible swelling of the surface layer of the cornea, which is known as corneal epithelial edema. Through testing it was determined that this product may have an elevated incidence of false positive results. A false positive test result could lead to the administration of antibiotics that are unnecessary. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. The root cause is still under investigation. The absolute range of IGFBP-3 levels determined using DSL-10-6600 IGFBP-3 Elisa, lot number 992743, is 3196 -10007 ng/ml. This is approximately 1.7 fold higher than the absolute range reported in the ifu (1500 - 5600 ng/ml). Beckman Coulter has confirmed that for lot numbers M908398 and M911529 of Immager Immunochemistry Systems Rheumatoid Factor Reagent, known negative results are being reported as slightly positive (between 20 and 30 iu/ml, usually). When tested on other methods or with other lots most of these slightly positive samples read < 20 iu/ml or negative. Per the CIS 95% of normal, healthy individuals who live in southern California should have results less than 20 iu/ml. Customers utilizing these lots are reporting patient results in more than 5% of their samples with results greater than 20 iu/ml.
Tremblay Harrison Minute Lab Strep A Rapid Test Device
Tremblay Harrison Inc.
2011-10-31
2011-09-18 67276
Type III
STW-A1
STA0010072, STA0110106, STA0110011, STA0100087
Active IGFBP-3 Elisa (Insulin like Growth Hormone)
2011-10-31
2011-03-28 62595
Type II
DSL-10-6600
990220, 991432, 991530, 991916, 992287
Immage Immunochemistry System RF Rheumatoid Factor Reagent
2011-10-31
2011-05-31 64398
Type III
447070
M908398, M911529
Senographe 2000D Mammography System
2011-10-31
2011-10-12 67204
Type II
S30321PZ
298660BU2, 379686BU9, 306445BU8, 420009BU3, 3364668BU2
Some Pacs and Workstations vendors implement a distance measurement calculation that is IHE compliant for magnified images. When sending magnified images acquired by GE Senographe 2000D Mammography Systems to these workstations, distance measurement may be inaccurate and the caregiver may underestimate a breast lesion/tumor. This issue does not exist for images done with contact mode. A combination of pixel spacing dicom tags and estimated radiographic magnification dicom tag, influence the measurement result of the magnified images on the diagnostic review workstation. In the mammography industry, the pixel spacing information has been coded in different ways since the introduction of digital images. The IHE Initiative established a clear recommendation, however, it has not been implemented by all systems. As the first company to create digital mammography images, GE has implemented a specific codification of the calibration of pixel size information that is not consistent with the more recent IHE recommendation. GE Senographe 2000D Full Field Digital Mammography System ( Seno2000D) systems implement this GE coding schema. Some non-GE review workstations may not be able to interpret this type of coding properly. Therefore, distance measurements on GE magnified images that are pushed to certain non-GE review workstations could cause lesion size measurement errors on magnified views. Additionally true size display or true size printing of magnified views on Dicom printers can also be affected. All GE multisystem review workstations (Seno Advantage 2.x and IDI) are now able to identify and correctly interpret both GE coding and ihe coding. GE Seno Advantage 1.x Review Workstation can only read GE coding. First field complaint received 05 May 11 from Poole Hospital NHS Foundation, UK. Receipt of RSRX product that was observed to measure approximately 16% below the activity stated within the associated i-125 sealed source calibration certificate (0.449 MCI). Second field complaint received may 18 from San Sebastian where the calibration strand was assayed and activity found to deviate from label by 8.3%. Two additional complaints were the orders determined to be mixed with Poole and San Sebastian. A button on the hand controller on the precedence and Skylight Spect Systems may become stuck, which may result in unintended motion of the detector which could cause the detector to come in contact with the patient if the operator is not diligently observing the scan. Reagents of specified lots failed QC requirements while within the assay stored calibration and onboard stability claims of 7 and 14 days respectively. This issue is detected through routine QC monitoring where results are out of the expected range values resulting in the failure of the Tobramycin Assay to meet the onboard stability claim. A problem was found during production with the part designed to mechanically connect the C-Arm to the stand. Due to an unintended external force, the front plate in this part broke into two pieces causing the C-Arm to suspend on the single central bolt. If this problem were to reoccur in the field, it could pose a risk for patients and others in close vicinity to the system. Continuous recycling and/or rebooting of Plum A+ devices (single and triple channel) may occur when the "backlight intensity" and/or "display contrast" settings for the lcd display have been adjusted from the original default setting. / Un recyclage et/ou une rinitialisation en continu des dispositifs Plum A+ ( canal simple ou triple) peuvent se produire lorsque les paramtres d' intensit du rtroclairage ou de contraste de l'affichage de l'cran ACL ont t modifis. Specified lots are not meeting the onboard stability claims. This issue is detected through routine quality control monitoring. QC results are out of the expected range values. / Les lots spcifis ne respectent pas les exigences en matire de stabilit en cours. Ce problme a t identifi pendant la surveillance de contrle de la qualit courante, o des rsultats taient en dehors de la plage de valeurs prvues. Philips has reports that the burned in mirror icon has been criticized by customers. The mirror icon could be interpretted as a right marker if the image is mirrored again within the PACS system. This could lead to a misdiagnosis. / La compagnie Philips a reu des plaintes de clients relativement l'icne en miroir imprime, qui pourrait tre prise tort pour le ct droit du patient si l'image est reproduite en miroir dans le systme PACS, ce qui pourrait entraner une erreur de diagnostic. There is a potential for a small amount of charge to build and be stored on the capacitor in between automatic daily measurements. This residual charge may result in an artificially low displayed lead impedance value in some cases. / Il existe un risque qu'une petite quantit de charge s'accumule sur le condensateur entre les prises de mesures automatiques quotidiennes. Cette charge rsiduelle peut entraner une lecture artificiellement faible de la valeur d'impdance de la sonde dans certains cas. Hospira received complaints relating to incorrect seating of the regulator closer. As a result of this failure, unrestricted flow may occur which could contribute to life-threatening adverse events. / Hospira a reu des plaintes relativement une mauvaise disposition du dispositif de fermeture du rgulateur. En raison de cette dfaillance, les liquides peuvent s'couler sans restriction, ce qui pourrait contribuer crer des vnements indsirables comportant un danger de mort.
Rapid Strand Rx Pre-loaded Brachytherapy Kit
Medi-Physics Inc., D.B.A. GE Healthcare
2011-10-31
2011-09-20 67281
Type II
I125RSRX-ROUND
N/A
A) Precedence System-16 Slice B) Precedence System-6 Slice C) Skylight Gamma Camera System
2011-10-31
2011-09-30 67583
Type II
A) 2619-3000A B) 2169-3002A C) 2160-3000A, 2160-3000B, 2161-3000B, 2161-3001B
Tobramycin Assay
Siemens Healthcare Diagnotsics Inc.
2011-10-31
2011-10-04 67585
Type III
00835186, 03329524
>20 Lot Numbers, Contact Manufacturer
A) BV Pulsera Mobile C-Arm System-9 In. And 12 In. Versions Philips Medical Systems Nederland BV B) BV Endura Mobile C-Arm System C) Veradius
2011-10-31
2011-10-03 67586
Type II
A) 718095 B) 718074 C) Veradius
A) Plum A+ Volumetric Infusion Pump B) Plum A+3 Infusion Pumps
Hospira Inc.
2011-11-14
2011-09-20 67069
Type II
A) 12391, 20679, 20792 B) 12678, 20678
A) >100 Numbers, Contact Manufacturer, >100 Numros, Contactez Fabriquant B) >100 Numbers, Contact Manufacturer, >100 Numros, Contactez Fabriquant
Thyroxine (T4) Assay
2011-11-14
2011-10-07 67589
Type III
08074354, 09236439
>10 Numbers, Contact Manufacturer, >10 Numros, Contactez Fabriquant
A) PCR Eleva S B) PCR Eleva S Plus C) PCR AC-500 / PCR AC-5000 Basic System D) PCR Eleva Corado
2011-11-14
2011-10-12 67759
Type II
A) PCR Eleva S B) PCR Eleva S Plus C) 989701000002 D) PCR Eleva Corado
A) Accent DR B) Accent DR RF C) Anthem CRT-P D) Anthem CRT-P RF
St. Jude Medical, Cardiac Rhythm Management Division
2011-11-14
2011-09-22 67287
Type II
A) PM2112 B) PM2212 C) PM3112 D) PM3212
A) Plum A+ Volumetric Infusion Pump B) Plum A+3 Infusion Pumps
Hospira Inc.
2011-11-14
2011-09-20 67860
Type I
A) 12391, 20679, 20792 B) 12678, 20678
A) >100 Numbers, Contact Manufacturer, >100 Numros, Contactez Fabriquant B) >100 Numbers, Contact Manufacturer, >100 Numros, Contactez Fabriquant
A) Drills / B) Burr - Diamond Ball C) Burr - Twist Drill /D) Burr - Fluted Ball E) Burr - Coarse Diamond Ball / F) Burr - Fluted Router G) Burr - Extra Coarse Diamond Ball H) Burr - Fluted Oval / I) Burr - Fluted Acorn J) Burr - Coarse Diamond Drum K) Burr - Extra Coarse Diamond Drum L) Burr - Fluted Pear / M) Burr - Fluted Matchstick N) Burr - Diamond Matchstick O) Burr - Diamond Disc / P) Burr - Side Cutter Q) Burr - Fluted Drum / R) Burr - Spiral Router S) Burr - Fluted Carbide Drum / T) Burr - Coring Tool U) Burr - Diamond Flame / V) Irrigation Clip W) Minimal Access Attachment System - Fluted Ball X) Minimal Access Attachment System - Diamond Ball Y) Minimal Access Attachment System - Coarse Diamond Z) Minimal Access Attachment System - Fluted Matchstick AA) Quick Disconnect Angle Attachment - Fluted Ball BB) Quick Disconnect Angle Attachment - Diamond Ball CC) Quick Disconnect Angle Attachment - Coarse Diamond Ball DD) Quick Disconnect Angle Attachment - Extra Coarse Diamond Ball EE) Quick Disconnect Angle Attachment - Fluted Oval FF) Quick Disconnect Angle Attachment - Fluted Matchstick GG) Quick Disconnect Angle Attachment - Fluted Drum HH) Micro Dissection Attachment System - Fluted Ball II) Micro Dissection Attachment System - Diamond Ball JJ) IMRI Fluted Ball / KK) Burr - Carbide Fluted Ball LL) Boring Tool
The Anspach Effort Inc.
2011-11-14
2011-09-09 67146
Type II
A) ADG-11, ADG-13 B) BLU-17-5, L-5D, L-6D, M-1B, M-2D, M-2SD, M-3D, M-6B, M-7B, MIA 16-4D, S-05D, S-15D, S-15SD, S1D, S-1SD, S-25D, S-25SD, S-2D, S-2SD, S-35D, S-3D, S-3SD, S-4D, S-5D, S-6D, SIL-17-3, SIL-17-6, TURQ-17-3, TURQ-17-5, TURQ-L17-3, VIO-17-2, VIO-17-3, VIO-17-5 / C) S-1254TD, S-1504TD, S1506TD, TURQ-436-6 D) BLA-7-9, BLU-6, BLU-7-9, L-2SB, L-3SB, L-3SD, L-4B, L-5B, L-6B, LHD-7B, M-2SB, M-3SB, M-4B, M8NS, RED-5, S-15B, S-15SB, S-1B, S-25B, S-25SB, S-2B, S-35B, S-35SB, S-3B, S-3SB, S-4B, S-5B, S6B, S-7B, S-8B, S-9B, SHD-6B, SIL-3, SIL-4, SIL-5, SIL-6, SIL-7, SIL-7-9, TURQ-L3, TURQ-L4, TURQL5, TURQ-L5, TURQ-L6, VIO-6 /E) L-3SDC, L-4DC, L-5DC, M-1SD, M-2B, M-3B, M-4DC, S-25DC, S25SDC, S-2DC, S-3DC, S-3SDC, S-4DC, S-5DC, S-6DC, S-8DC, TURQ-L17-75C / F) A-CRN, BLA-1, BLA-2, BLA-7, BLU-2XL, CDA-IR, GRE-1, L-1R, L-CRN, P-CRN, RED-1, S-1R, S-6R, SHD-6R, SIL-0, SIL-1,SIL-2, TURQ-1, VIO-1, VIO-2, VIO-2XL, XLHD-25HR G) L-4DX, S-4DX, S-5DX, S-6DX / H) M-5D, S-40V, VIO-40-4 I) BLU-32, BLU-38, M-5DC, RED-32, RED-38, S-5AC, S-6AC, S-9AC, SHD-6AC, SHD-75AC, SHD-9AC, SIL-32, SIL-38, VIO-32, XLHD-75AC / J) S-68DRMDC / K) BLU-9DCX /L) SIL-21 M) BLU-8, GREY-MIA- 20-8, L-8N, L-8NS, L-8NS-M, M-8NSD, MHD-15C, S-8N, S-8N-18, S-8NS, S-8NSM, SHD-8NS, SIL-8, TURQ-8, TURQ-L8, TURQ-L8-18, VIO-8, XLHD-8NS N) M-8NS, MHD-16CT, SIL-8D-32 / O) BLU-14, MHD-25DD, SHD-17DD, SHD-25DD, SIL-14, SIL-14-17, VIO-14 P) SIL-15 / Q) BLA-9, L-35DR, LHD-64DRM, RED-9, XLHD-95DRM / R) A-CRN-S, ADG-10, GRE-1S, LCRN-S / S) MHD-3DRMC / T) MHD-19CT / U) M-5B / V) IRR-CLIP-10, IRR-CLIP-20, IRR-CLIP-40, IRRCLIP-50, IRR-CLIP-60 / W) MA10-2SB, MA15-2SB, MA15-3SB / X) MA10-2SD, MA15-2SD, MA15-3SD, MA15-4D Y) MA15-8NSDC / Z) MA15-8N, MA15-8NS / AA) QD11-2SB, QD11-3SB, QD11-4B, QD11-5B, QD11-6B, QD14-3SB, QD14-4B, QD14-5B, QD14-6B, QD8-2SB, QD8-3SB, QD8-4B, QD8-5B, QD8-6B BB) QD11-3SD. QD11-5D, QD14-4D, QD8-1SD, QD8-25SD, QD8-2SD, QD8-3SD, QD8-4D, QD8-5D CC) QD11-4DC, QD11-5DC, QD8-3SDC, QD8-4DC / DD) QD11-5DX / EE) QD8-40V FF) QD11-8N, QD11-8NS, QD14-8N, QD14-8NS, QD8-8N, QD8-8N-18, QD8-8NS / GG) QD11-4DRM HH) MDA-2SB, MDA-3SB / II) MDA-2SD, MDA-3SD, MDA-4D JJ) IMRI-SHD-6B / KK) S-2B-C, S-3B-C, S-4BL-C, S-5B-C LL) MHD-97B, MHD-98B, SIL-20, SIL-24
A) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant / B) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant C) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / D) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / E) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant / F) >10 Numbers, Contact Manufact urer, / > 10 Numros, Contactez Fabriquant / G) B453013691, 333305, 330625, 333623, 318537, 333620,334122, 334181, 333286 / H) 318472, 335184, 334555, 333162 / I) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant J) C463028160, B263009386, C103018318, B103005206, C113018978, B163006632, C053017429, B333010929, B033002563 / K) B273009628 /L) D143031700 / M) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / N) 319516, C303023967, A503001714, C533029521, C503029185, 320176, B0403003015, 330793, 332554 / O) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / P) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / Q) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / R) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / S) B073004259 / T) B183006740 / U) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / V) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / W) C493028995, B383012019, C233019979, B033002458, A513001743 / X) C503029180, B133005832, B153006396, B113005451, B093004851, A513001763, A513001821 / Y) C293023615 / Z) B493014178, C213021949, C363025427, C383025888 / AA) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / BB) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant / CC) 330061, 330834, 332184, 333498, 334163, 332482, B503014848, B043003143, A513001783, 332842, 331129 / DD) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant / EE) 332291, 331887 / FF) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / GG) 320193, 330423, 330709, 333007 / HH) >10 Numbers, Contact Manufacturer, / > 10 Numros, Contactez Fabriquant / II) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant / JJ) 333148 / KK) B053003293, B463014365, B453013945, B453013962, C023014787 / LL) >10 Numbers, Contact
Failure in the packaging configuration (packaged in a tyvek pouch/tube configuration) that is not capable of maintaining a sterile barrier through the labelled shelf life of five years. / Une mauvaise configuration d'emballage (sachet/tube tyvek) qui ne pourrait pas maintenir une barrire strile durant la dure de conservation de cinq ans inscrite sur l'tiquette.
Cobas Integra Theophylline for Cobas C Systems
2011-11-14
2011-09-29 67460
Type III
4491025190
64020901
Cobas E 411 Immunoassay Analyzer
2011-11-14
2011-10-06 67569
Type III
04775201001, 04775279001
N/A
A possible elevated recovery in patient samples is observed with the Cobas Integra Theophylline for Cobas C Systems of lot # 64020901. / Un possible rtablissement plus lev est observ dans les chantillons de patients avec la thophylline Cobas Integra pour systmes Cobas C du lot 64020901. The pinch valve tubing has to be exchanged more frequently than recommended when the sample reception mode is selected for 8 hours. / Les tubes de robinet manchon doivent tre remplacs plus souvent que la frquence recommande lorsque le mode de rception d'chantillons choisi est de 8 heures. A batch of Isoline Defibrillation Leads was labelled with an incorrect use before date (UBD), which was greater than the maximum of 36 months shelf life. The date printed on the labels was 5 May 2013, while the correct UBD is 21 September 2012. / Les tiquettes d'un lot de sondes de dfibrillation Isoline portaient une date de premption errone, qui dpassait la dure de conservation de 36 mois. La date imprime sur les tiquettes tait le 5 mai 2013, alors que la date de premption aurait d tre le 21 septembre 2012.
Isoline 2CR6 Defibrillation Leads
Sorin CRM S.R. L.
2011-11-14
2011-10-20 67993
Type II
2CR-6
S2CR605346, S2CR605347
A) Painsmart IOD (Ambulatory Infusion Pump) B) 6000 CMS (Ambulatory Infusion Pump) C) 4000 CMS (Ambulatory Infusion Pump)
Zevex Inc. Also trading as Moog Medical Devices Group
2011-11-14
2011-04-04 62624
Type I
A) 360-1200, 360-1300, 360-1300P B) 360-1100, 360-1400 C) 350-1000, 350-1100, 350-1200
A) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant B) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant C) >10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant
Accuracy of infusion with a syringe varies widely depending on the medication and stiction between the barrel and plunger of individual syringes. The effects of the variables have made the accuracy difficult to evaluate as each condition produces differing effects from the syringe variables. Therefore, Zevex is not confident in providing accuracy percentages for syringes as they may be misleading if the application conditions are also considered. As a result, the labeling will be modified to indicate the accuracy of delivery from a syringe cannot be guaranteed. / La prcision de l'infusion au moyen d'une seringue varie considrablement en fonction du mdicament et du frottement entre le corps et le piston de seringues individuelles. Les effets des variables ont rendu la prcision difficile valuer puisque chaque type de condition produitdivers effets selon les variables de la seringue. Pour cette raison. Zevex prfre ne pas fournir de pourcentages de prcision pour les seringues, car ils peuvent induire en erreur si l'on prend en compte les conditions de l'application. En consquence, l'tiquetage sera modifi de manire indiquer que la prcision d'administration d'une seringue ne peut pas tre garantie.
A) Brilliance ICT System - System B) Brilliance ICT SP System - Main
2011-11-14
2011-10-13 67753
Type III
A) 728306 B) 728311
A) N/A B) N/A
The Common Image Reconstruction System (CIRS) encounters an error and requires reboot of the system. Raw data that has been previously acquired will not be lost. / Le systme de reconstruction d'image affiche un message d'erreur et doit tre redmarr. Les donnes brutes acquises prcdemment ne seront pas perdues. Some of the Vacuette Quickshield with snappy safety holder have a crack at the hub, which could cause the threaded neck that holds the needle to break off and expose the needle. / Certains des Quickshield with snappy safety holder Vacuette prsentent une fissure au niveau du raccord, ce qui pourrait faire en sorte que le collet filet qui retient l'aiguille se brise et expose ainsi l'aiguille. GE Healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your Revolution XR/D X-ray systems that may impact patient safety. The hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. Should this happen during patient loading or unloading, patient injury could occur. / GE Healthcare a constat qu'il existe un problme possible associ la poigne se trouvant sur la table de vos systmes de radiographie X Revolution XR/D et que ce problme peut nuire la scurit des patients. La poigne pourrait ne pas tre bien fixe et elle pourrait se dtacher au cours de l'utilisation du systme. Si la poigne se dtache alors que des patients embarquent sur le systme ou en dbarquent, ces derniers pourraient tre blesss.
QuickShield with Snappy Safety Holder
Greiner Bio One GMBH
2011-11-14
2011-08-11 67933
Type II
450254
B041104, B011101, B051105, B071106, B071004, B071005, B081006, B121009, B011102, B021103
Revolution XRD X-Ray Systems
GE Medical Systems, LLC
2011-11-14
2011-10-24 67286
Type II
2259988-2, 2351505
N/A
Nexgen CKS Prolong-LPS Mobile Articular
Zimmer Inc.
2011-11-14
2011-10-19 68044
Type II
00594703012, 00594706012
61732058, 61732066
Zimmer has initiated a recall of the nexgen complete knee solution Prolong LPS-Mobile Articular Surface because of a device packaging mix-up. The packaging is labeled as a 005947-030-12 size c 12mm height use with plate 2,3,4 but contains a 00-5947-060-12 size F 12mm height use with plate 5,6,6 Articular Surface and vice versa. / Zimmer a mis un rappel pour la solution de genou complte Nexgen Prolong LPS-Mobile Articular Surface, en raison d'un mlange d'emballage des dispositifs. Il est indiqu ce qui suit sur l'emballage: 00-5947-030-12, taille c, 12 mm de hauteur, utiliser avec les plateaux 2,3,4, mais il devrait plutt tre indiqu ce qui suit: 00-5947-060-12, taille F, 12 mm de hauteur, utiliser avec les plateaux 5,6,6 Articular Surface et vice versa. Weakened reactivity and negative results when using Lot 34161 of the product. / Ractivit plus faible et rsultats ngatifs lorsqu'on utilise le lot 34161 du produit. Philips has become aware of an issue that may be encountered when completing a specific workflow which may result in the system providing inaccurate ejection fraction information. / Philips a constat qu'un problme peut tre rencontr lors de l'accomplissement de tches spcifiques, ce qui peut faire en sorte que le systme fournisse des donnes de fraction d'jection incorrectes. Internal investigation revealed the instability of an enzyme in RL which is used to suppress the ascorbic acid interference. / Une enqute interne a rvl l'instabilit d'un enzyme dans le RL utilis pour supprimer l'interfrence d'acide ascorbique. A packaging discrepancy was identified in specific Lots of Stryker's Duration packaging. It was found that the outer blister container did not meet Stryker's internal packaging specifications: Specifically, seal width and/or breach of the outer seal. Each potentially affected duration packaging unit includes an inner and outer blister container. The inner blister was found intact, and product sterility was not ompromised. / On a remarqu la prsence d'une anomalie dans un lot spcifique d'emballages Duration de Stryker. On a constat que l'emballage coque extrieur n'tait pas conforme aux spcifications d'emballage intrieur de Stryker, relativement la largeur du joint et/ou une perforation du joint extrieur. Chaque emballage Duration possiblement compromis comprend des emballages coques extrieur et intrieur. L'emballage coque intrieur tait intact et la strilit du produit n'a pas t compromise.
Complement Control Cells
Immucor Inc.
2011-11-14
2011-10-20 68281
Type II
7930
34161
NM Application Suite
2011-11-14
2011-10-12 67756
Type II
453560477471
N/A
A) Hitachi LDL-Cholesterol, No Pretreatment, LDL-C Plus 2nd GEN B) Hitachi LDL-C Plus C) Cobas C111 LDL-Cholesterol (LDL_C)
2011-11-14
2011-10-07 68127
Type III
A) 03038866322 B) 04711220190, 04714423190 C) 05401682190
A) 630746-01, 637097-01, 644941-01 B) 630737-01, 637092-01, 644936-01, 63078701, 637065-01, 644933-01 C) 630749-01, 637101-01, 644944-01 A) All / Tous B) All / Tous C) All / Tous D) All / Tous E) All / Tous F) All / Tous G) All / Tous H) All / Tous I) All / Tous J) All / Tous K) All / Tous L) All / Tous M) All / Tous N) All / Tous O) All / Tous P) All / Tous Q) All / Tous R) All / Tous S) All / Tous
A) Kinematic II Rotating Hinge Total Knee System HowMedica Osteonics Corporation B) HowMedica Modular Resection System - Proximal Tibia C) Souter Strathclyde Elbow Prothesis Ulnar Component D) Modular Replacement System - Kinematic Rotating Hinge KN Met Tib Insert E) Modular Replacement Sytem - Kinematic Knee All Poly Tibial Plug F) Eius Knee System - Tibial Components G) Modular Rotating Hinge Knee System - Femoral Components H) Modular Rotating Hinge Knee System - Tibial Inserts / Components/ Sleeve I) Modular Rotating Hinge Knee System - Bumpr Insert / Axle J) Kinematic II - Duration Poly Dome Patella with 3 Pegs K) Avon Patello-Femoral Joint - Patella Component L) Duracon ISA Mobile Bearing Knee Tibial Insert M) Global Modular Replacement System - Bushing N) Global Modular Replacement System - Proximal Tibial Insert O) Kinemax Plus Total Knee System - Stabilizer Tibial Components P) Kinemax Plus Total Knee System - Patellar Components Q) Kinemax Plus Total Knee System - Condylar Tibial Components R) Duracon Total Knee System - CS Lipped Tibial Insert S) Kinematic II Modular Condylar Tibila Inserts
2011-11-14
2011-09-06 67002
Type II
A) 6485-4-100 / B) 6465-6-007, 6465-6-018, 6466-4-308, 6466-9-100, 6466-9-200, 6466-9-240, 6466-9245, 6466-9-306 / C) 6944-1-120, 6944-2-220 / D) 6485-2-008, 6485-2-011, 6485-2-016, 6485-2-021, 64852-108, 6485-2-111, 6485-2-116, 6485-2-121, 6485-2-208, 6485-2-211, 6485-2-216, 6485-2-221, 6485-2308, 6485-2-311, 6485-2-316, 6485-2-321, 6485-2-408, 6485-2-411, 6485-2-416, 6485-2-421, 6485-2-460, 6485-2-465, 6485-2-508, 6485-2-511, 6485-2-608, 6485-2-611, 6485-4-111, 6485-4-113, 6485-4-116, 6485-4-121, 6485-4-211, 6485-4-213, 6485-4-216, 6485-4-221 / E) N/A / F) 6636-2-308, 6636-2-309, 66362-310, 6636-2-312, 6636-2-318, 6636-2-319, 6636-2-320, 6636-2-322, 6636-2-408, 6636-2-409, 6636-2410, 6636-2-412, 6636-2-418, 6636-2-419, 6636-2-420, 6636-2-422, 6636-2-508, 6636-2-509, 6636-2-510, 6636-2-512, 6636-2-518, 6636-2-519, 6636-2-520, 6636-2-522, 6636-2-608, 6636-2-609, 6636-2-610, 6636-2-612, 6636-2-618, 6636-2-619, 6636-2-620, 6636-2-622, 6636-2-708, 6636-2-709, 6636-2-710, 6636-2-712, 6636-2-718, 6636-2-719, 6636-2-720, 6636-2-722. / G) 6481-2-150 / H) 6481-2-140, 6481-3210, 6481-3-213, 6481-3-216, 6481-3-220, 6481-3-224, 6481-3-310, 6481-3-313, 6481-3-316, 6481-3-320, 6481-3-324 / I) 6481-2-110, 6481-2-130, 6481-2-133 / J) 6485-1-915, 6485-3-915, 6485-5-915 / K) 64300-020, 6430-0-030, 6430-0-040 / L) 6642-2-009, 6642-2-011, 6642-2-013, 6642-2-016, 6642-2-209, 6642-2211, 6642-2-213, 6642-2-216, 6642-2-409, 6642-2-411, 6642-2-413, 6642-2-416, 6642-2-609, 6642-2-611, 6642-2-613, 6642-2-616, 6642-3-009, 6642-3-011, 6642-3-013, 6642-3-016, 6642-3-209, 6642-3-211, 6642-3-213, 6642-3-216, 6642-3-409, 6642-3-411, 6642-3-413, 6642-3-416, 6642-3-609, 6642-3-611, 6642-3-613, 6642-3-616 / M) 6495-2-105 N) 6495-3-010, 6495-3-013, 6495-3-016, 6495-3-020, 6495-3-024 / O) 6479-5-508, 6479-5-510, 6479-5512, 6479-5-515, 6479-5-518, 6479-5-608, 6479-5-610, 6479-5-612, 6479-5-615, 6479-5-618, 6479-5-621, 6479-5-708, 6479-5-710, 6479-5-712, 6479-5-715, 6479-5-718, 6479-5-721, 6479-5-725, 6479-5-808, 6479-5-810, 6479-5-812, 6479-5-815, 6479-5-818, 6479-5-821, 6479-5-908, 6479-5-910, 6479-5-912, 6479-5-915, 6479-5-918, 6479-5-921, 6479-5-925 / P) 6479-4-900, 6479-4-911, 6479-4-920 / Q) 6479-5008, 6479-5-010, 6479-5-012, 6479-5-015, 6479-5-018, 6479-5-021, 6479-5-025, 6479-5-108, 6479-5-110, 6479-5-112, 6479-5-115, 6479-5-118, 6479-5-121, 6479-5-125, 6479-5-208, 6479-5-210, 6479-5-212, 6479-5-215, 6479-5-218, 6479-5-221, 6479-5-225, 6479-5-308, 6479-5-310, 6479-5-312, 6479-5-315, 6479-5-318, 6479-5-321, 6479-5-325, 6479-5-408, 6479-5-410, 6479-5-412, 6479-5-415, 6479-5-418, 6479-5-421, 6479-5-425 R) N/A / S) 6471-0-808, 6471-0-811, 6471-0-813, 6471-0-816, 6471-3-808, 64713-811, 6471-3-813, 6471-3-816, 6471-5-808, 6471-5-811, 6471-5-813, 6471-5-816
Shoulderflex Massager
King International: An Innovative Health & Wellness Products Company
2011-11-14
2011-08-30 Type II
67022
N/A
N/A
Recall of Shoulderflex due to one death and one near-strangulation (not in Canada). Users are recommended to destroy the device as per manufacturer's instructions. / Rappel de Shoulderflex en raison d'un dcs etd'un incident d'touffement vit (en dehors du Canada). On recommande aux utilisateurs de dtruire ce dispositif conformment aux instructions du fabricant. Abbott Point of Care Inc. (APOC) has determined that lots of I-Stat CTNI cartridges beginning with the letter "T" may exhibit a higher than expected variability in reported results. All other CTNI lots are unaffected by this issue. This increased variability may result in falsely elevated or falsely depressed results. / Abbott Point of Care Inc. (APOC) a constat que les lots de I-Stat CTNI cartridges dbutant par la lettre T peuvent prsenter une variabilit des rsultats plus leve que prvue. Tous les autres lots de CTNI ne sont pas touchs par ce problme. Cette variabilit plus leve peut entraner des rsultats faussement levs ou bas. Abbott Diagnostics is recalling Clinical Chemistry Urea Nitrogen Reagent lots 97642UN11 & 97668UN11 due to particulate matter in some reagent cartridges. The particulate matter has been identified as an aureobasidium species which alone does not represent a hazard, but generates visible matter within the reagent cartridge, and may cause discoloration over time. / Abbott Diagnostics a mis un rappel pour les lots 97642UN11 et 97668UN11 de ractifs d'azote urique de chimie clinique en raison de la prsence de matires particulaires danscertaines cartouches de ractifs. Les matires particulaires ont t identifies comme tant une espce d'aureobasidium qui ne reprsente pas, par elle-mme, un danger, mais qui produit des matires visibles dans une cartouche de ractif et peut causer une dcoloration au fil du temps. Wrong issue of user instruction supplied with probes, as a consequences the incorrect method of sterilization may be used. / On a fourni la mauvaise version des instructions avec la sonde. Par consquent, on pourrait utiliser la mauvaise mthode de strilisation.
I-Stat 1 Analyzer System - CTNI Cartridge, Controls and Calibrators
2011-11-14
2011-09-30 Type III
67584
06F15-03
> 10 Numbers Contact Manufacturer, > 10 Numros, Contactex Fabriquant
Architect System - Urea Nitrogen Assay
2011-11-14
2011-10-07 Type III
67588
7D75-21, 7D75-31
97642UN11, 97668UN11
A) Cryomatic System - Retinal Probe B) Cryomatic System - Intra Vitreal Probe C) Cryomatic System - Curved Cataract Probe D) Cryomatic System - Collins Trichiasis
Keeler Limited
2011-11-14
2011-08-12 Type III
67622
A) 2509-P-8000, 2509-P-8001, 2509-P-8002 B) 2509-P-8003 C) 2509-P-8004 D) 2509-P-8006
Architect "I" System - Cyclosporine Assay
2011-11-14
2011-10-14 Type II
67747
1L75-01, 1L75-25, 1L75-55
> 10 Numbers Contact Manufacturer, > 10 Numros, Contactex Fabriquant
Abbott has confirmed that the ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision. Abbott has determined that the imprecision is due to an interaction between the ARCHITECT Cyclosporine assay and the resin used to produce certain ARCHITECT Reaction Vessel (RV) lots. Assay precision can be impacted if RV lots containing different resin are mixed in the ARCHITECT hopper and used to test ARCHITECT Cyclosporine. At this time, there is no data that indicates there is impact to other ARCHITECT assays. We are continuing to investigate this issue.
Abbott M2000 System - M2000SP Instrument
Abbott Molecular Inc.
2011-11-14
2011-10-14 Type II
67764
9K14-01, 9K14-02
N/A
There have been two reported instances in which the liquid waste sensor and components in the M2000SP lower instrument cabinet overheated or caught fire. In both cases the event was contained within the lower cabinet of the M2000SP. There were no injuries. / On a signal deux incidents lors desquels le capteur de dchets liquides et les composants de l'armoire infrieure de l'instrument M2000SP ont surchauff ou ont pris feu. Dans les deux cas, l'incident a t limit l'armoire infrieure de l'instrument M2000SP. Il n'y a eu aucun bless. An equivocal results obtained with the strain Streptococcus Pyogenes ATCC 19615 and the R1 Reagent (Anti-Streptpcoccus Pneumoniae Latex) indicates a deterioration of the reagent. In this case, these reagents can not be used. / Les rsultats quivoques obtenus l'aide de la souche ATCC 19615 de la bactrie Streptococcus Pyogenes et du ractif R1 (Anti-Streptpcoccus Pneumoniae Latex) indiquent une dtrioration du ractif. Dans ce cas, ces ractifs ne peuvent pas tre utiliss. Beckton Dickinson has received reports that the oral syringe tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe. / Beckton Dickinson a reu des rapports selon lesquels les embouts des seringues orales pourraient se dtacher de la seringue, ce qui pourrait faire en sorte que le mdicament coule hors de la seringue.
Slidex Pneumo Kit
bioMerieux SA
2011-11-14
2011-10-06 Type II
67824
58821
1101103874
A) 1 mL BDT Oral Syringe with tip cap, amber B) 1 mL BDT Oral Syringe with tip cap, clear C) 3 mL BDT Oral Syringe with tip cap, amber D) 3 mL BDT Oral Syringe with tip cap, clear E) 5 mL BDT Oral Syringe with tip cap, amber F) 5 mL BDT Oral Syringe with tip cap, clear G) 10 mL BDT Oral Syringe with tip cap, amber H) 10 mL BDT Oral Syringe with tip cap, clear
Becton Dickinson and Company
2011-11-14
2011-10-06 Type III
67964
A) 305207 B) 305217 C) 305210 D) 305220 E) 305220 F) 305218 G) 305209 H) 305219
A) 0296609, 0323224, 0323225, 1003684, 1027148, 1052674 B) 0267425, 0267426, 1027168 C) 0294726, 0323228, 1052682 D) 1052683 E) 0294731, 1003692, 1027154 F) 0296605, 0323230, 0323231, 1003683, 1027175, 1042244 G) 1003693, 1027159 H) 0240048, 0296614, 1003672, 1027179, 1052688 A) >10 Numbers Contact Manufacturer, >10 Numros, Contactex Fabriquant B) >10 Numbers Contact Manufacturer, >10 Numros, Contactex Fabriquant C) >10 Numbers Contact Manufacturer, >10 Numros, Contactex Fabriquant D) >10 Numbers Contact Manufacturer, >10 Numros, Contactex Fabriquant N/A
A) Vitek 2 Compact 30 System B) Vitek 2 Compact 60 System C) Vitek 2 Instrument D) Vitek 2 XL Instrument
bioMerieux Inc.
2011-11-14
2011-10-19 Type III
68240
A) W0452 B) W0452 C) W0452 D) W0452
Incorrect version of the English language Vitek 2 Systems Software User Manual dated 03/2010 was inadvertently installed on the hard drives of some new and refurburbished computers containing Vitek 2 Systems Software Version 5.01 / La mauvaise version du manuel anglais de l'utilisateur du logiciel de systmes Vitek 2, dat du 03/2010, a t installe sur les disques durs de certains ordinateurs neufs et remis en tat munis de la version 5.01 du logiciel de systmes Vitek 2.
Cobas C111 with ISE Stand Alone Configuration
2011-11-14
2011-10-18 Type II
68296
4777433001
The manufacturer received complaints reporting that on result printouts, one or more numbers or caracters can be missing. It has been observed that the printer may skip leading blanks which may result in a wrong printing layout. The missing numbers or characters can affect every kind of printout like results, measurement units or other text. / Le fabricant a reu des plaintes selon lesquelles un ou plusieurs chiffres ou caractres pourraient tre manquants sur les copies papier des rsultats. On a constat que l'imprimante peut sauter les espaces gauche, ce qui peut causer des erreurs lors de l'impression. Les chiffres ou caractres manquants peuvent avoir une incidence sur tous les types d'imprims, comme des rsultats, des units de mesure ou d'autre texte. Certain lot numbers of the individual syringe packages labelled to contain the Illumina 150ml Linden Luer Syringe with Handi-Fil Straw, catalogue number 900103, may contained the similar product, the Illumena 150ml Regular Luer Syringe with Handi-Fil Straw, catalogue number 900101. / Certains numros de lots d'emballages de seringues individuelles dont l'tiquette mentionne que l'emballage contient la seringue Illumina 150 ml Linden Luer Handi-Fil Straw, numro de catalogue 900103, pourraient en fait contenir un produit semblable, la seringue Illumena 150 ml Regular Luer Handi-Fil Straw, numro de catalogue 900101. A problem has been confirmed the Slidex Staph Plus Reagent which could lead to false positive results with S.Non-Aureus strains. BioMerieux have not been able to resolve the issue and decided to temporarily suspend production and sale of new batches of Slidex Staph Plus. / On a confirm la prsence d'un problme avec le ractif Slidex Staph Plus qui pourrait entraner des rsultats faussement positifs avec les souches S.Non-Attreus. BioMerieux n'a pas t en mesure de rsoudre le problme et a donc dcid d'arrter la production temporairement et de vendre un nouveau lot de Slidex Staph Plus. Certain lots of the Cobas Ampliprep instrument, samples input barcode clips may have irregular inner surfaces which can cause the sample input tubes to remain lodged in the barcode clips. / Les clips de code barres d'entre d'chantillons de certains lots d'instrument Cobas Ampliprep pourraient prsenter des surfaces intrieures irrgulires, ce qui pourrait faire en sorte que les tubes d'entre d'chantillons demeurent coincs dans les clips de code barres.
Illumena 150ml Linden Luer and Regular Luer Syringes with Handi-Fil Straw
Liebel-Flarsheim Company
2011-11-14
2011-10-26 Type III
68378
900101, 900103
>10 Numbers Contact Manufacturer, >10 Numros, Contactex Fabriquant
Slidex Staph Plus
bioMerieux SA
2011-11-14
2011-10-25 Type II
68387
73115, 73116
>10 Numbers Contact Manufacturer, >10 Numros, Contactex Fabriquant
Cobas Ampliprep Sample Tubes
2011-11-14
2011-10-21 Type III
68298
3137040001
11500503, 11504503, 11510503, 11513503, 11515503
A) Soft Reline Kits (Both Heat and Self Cure) B) Self Cure Repair Acrylic C) Heat Cure Denture Acrylic D) Tooth Acrylics E) Silver and Gold post solder F) Super Bonding Kit G) UBAR Kit (Metal Bonding Acrylic)
Protech Professional Products Inc.
2011-11-28
2011-10-11 66738
Type II
A) Starting with LR, Starting with RL B) Starting with PLU C) Starting with PDA D) RUC59, RUC%(A, RUC59A!, RUC59LB, RUC61, RUC61A, RUC61A1, RUC61LB, RUC62, RUC62A1, RUC62LB, RUC65, RUC65A, RUC65A1, RUC65LB, RUC66, RUC66A, RUC66A1, RUC66LB, RUC67, RUC67A, RUC67A1, RUC67LB, RUC69, RUC69A, RUC69A1, RUC69LB, RUC77, RUC77A, RUC77A1, RUC77LB, RUC81, RUC81A, RUC81A1, RUC81LB, RUC85, RUC85A, RUCA1, RUC85LB, RUC87, RUC87A, RUC87A1, RUC87LB, RUCBW, RUCDI, RUCDIA, RUCDIA1, RUCDILB, RUCLI, RUCLIA, RUCLILB, RUCOW, RUCOWA, RUCOWA1, RUCOWOLB, RUCPO,RUCPOA, RUCPOA1, RUCPOLB, RUCUW, RUCUWA1 E) CSS1, CSS3, GDS1, GDS3 F) SBA11, SBA12, SBL12, SBT12 G) RUCVPG, Starting with RUC11, Starting with RUCV11
Products are not licensed.
LABScreen Product-LABScreen MICA Single Antigen -Group 1 One Lambda Inc
2011-11-28
2011-07-18 66894
Type III
N/A
Penlon Crystal Laryngoscope Blades
Penlon Limited
2011-11-28
2011-09-21 67582
Type II
50674, 50675
Cervicore Chisel Guide
Stryker Spine SAS
2011-11-28
2011-10-07 67587
Type II
48290110
A) ZMR Hip System Taper Stems B) ZMR Hip System Spout Body C) ZMR Hip System Cone Body D) ZMR Hip System Calcar Body E) ZMR Hip System Splined Stems F) ZMR Hip System Porous Stems G) ZMR Hip System Spout AA Body H) ZMR Hip System Cone AA Body I) ZMR Hip System Calcar AA Body J) ZMR Hip System Porous Stems, Line Ext. K) ZMR Hip SystemSlotted Porous Bow. Stem
Zimmer Inc.
2011-11-28
2011-10-25 68351
Type I
A) 00-9982-014-13, 00-9982-014-18, 00-9982-015-13, 00-9982-015-18, 00-9982-016-13, 00-9982-016-18, 00-9982-016-23, 00-9982-017-13, 00-9982-017-18, 00-9982-017-23, 00-9982-018-13, 00-9982-018-18, 009982-018-23, 00-9982-019-13, 00-9982-019-18, 00-9982-019-23, 00-9982-020-18, 00-9982-020-23, 009982-022-18, 00-9982-022-23 / B) 00-9990-017-40, 00-9990-017-46, 00-9990-018-40, 00-9990-018-46, 009990-019-40, 00-9990-019-46, 00-9990-020-40, 00-9990-020-46, 00-9990-021-40, 00-9990-021-46, 009990-023-40, 00-9990-023-46, 00-9991-017-45, 00-9991-017-55, 00-9991-018-45, 00-9991-018-55, 009991-017-45, 00-9991-019-45, 00-9991-019-55, 00-9991-020-45, 00-9991-020-55, 00-9991-021-45, 009991-021-55, 00-9991-023-45, 00-9991-023-55, 00-9997-017-45, 00-9997-017-55, 00-9997-018-45, 009997-018-55, 00-9997-019-45, 00-9997-019-55 / C) 00-9993-017-35, 00-9993-017-45, 00-9993-017-55, 009993-018-35, 00-9993-018-45, 00-9993-018-55, 00-9993-019-35, 00-9993-019-45, 00-9993-019-55, 009993-020-35, 00-9993-020-45, 00-9993-020-55, 00-9993-021-35, 00-9993-021-45, 00-9993-021-55, 009993-023-35, 00-9993-023-45, 00-9993-023-55, 00-9996-017-35, 00-9996-017-45, 00-9996-017-55, 009996-018-35, 00-9996-018-45, 00-9996-018-55, 00-9996-019-35, 00-9996-019-45, 00-9996-019-55, 009996-020-35, 00-9996-021-35, 00-9996-023-35 / D) 00-9994-017-45, 00-9994-017-55, 00-9994-018-45, 009994-018-55, 00-9994-019-45, 00-9994-019-55, 00-9994-020-45, 00-9994-020-55, 00-9994-021-45, 009994-021-55, 00-9994-023-45, 00-9994-023-55, 00-9998-017-35, 00-9998-017-45, 00-9998-017-55, 009998-018-35-00-9998-018-45, 00-9998-018-55, 00-9998-019-35, 00-9998-019-45, 00-9998-019-55 / E) 009980-120-21, 00-9980-120-22, 00-9980-120-32, 00-9980-135-21, 00-9980-135-22, 00-9980-135-32, 009980-135-33, 00-9980-150-21, 00-9980-150-22, 00-9980-150-32, 00-9980-150-33, 00-9980-165-21, 009980-165-22, 00-9980-165-32, 00-9980-165-33, 00-9980-180-21, 00-9980-180-22, 00-9980-180-32, 009980-180-33, 00-9980-195-21, 00-9980-195-22, 00-9980-195-32, 00-9980-195-33, 00-9980-210-22, 009980-210-22, 00-9980-210-32, 00-9980-210-33, 00-9980-225-22, 00-9980-225-32, 00-9980-225-33, 009980-240-22, 00-9980-240-32, 00-9980-240-33, 00-9980-255-22, 00-9980-255-32, 00-9980-255-33 / F) 009981-120-21, 00-9981-120-22, 00-9981-120-32, 00-9981-135-21, 00-9981-135-22, 00-9981-135-32, 009981-135-33, 00-9981-150-21, 00-9981-150-22, 00-9981-150-32, 00-9981-150-33, 00-9981-165-21, 009981-165-22, 00-9981-165-32, 00-9981-165-33, 00-9981-180-21, 00-9981-180-22, 00-9981-180-32, 009981-180-33, 00-9981-195-21, 00-9981-195-22, 00-9981-195-32, 00-9981-195-33, 00-9981-210-33, 009981-225-33 / G) 00-9940-016-36, 00-9940-016-40, 00-9990-016-36, 00-9990-016-40 / H) 00-9941-01635, 00-9942-016-35, 00-9943-016-35, 00-9996-016-35 / I) 00-9946-016-35, 00-9947-016-35, 00-9948-01635, 00-9998-016-35 / J) 00-9981-210-22, 00-9981-210-32, 00-9981-225-22, 00-9981-225-32, 00-9981-24022, 00-9981-240-32, 00-9981-240-33, 00-9981-255-22, 00-9981-255-32, 00-9981-255-33 / K) 00-9983-12032, 00-9983-135-32, 00-9983-135-33, 00-9983-150-32, 00-9983-150-33, 00-9983-150-34, 00-9983-165-32, 00-9983-165-33, 00-9983-165-34,00-9983-180-32, 00-9983-180-33, 00-9983-180-34, 00-9983-195-32, 009983-195-33, 00-9983-195-34, 00-9983-210-32, 00-9983-210-33, 00-9983-210-34, 00-9983-225-323, 009983-225-33, 00-9983-225-34, 00-9983-240-32, 00-9983-240-33, 00-9983-240-34, 00-9983-255-32, 009983-255-33, 00-9983-255-34
LSMICA001-002, LSMICA001-003, LSMICA001- A false reaction maybe observed with the Mica019 antigen. Upon investigation, trnsfected 004 Mica019 cell lines (RC1223) demonstrated a lack of or presence of recombinant Mica019 inserts. All / Tous Penlon has been made aware of an incident where Mac 3 blades have been incorrectly packaged in disposable bags labelled as Mac 4 and then packed in a carton stating size Mac 4. 07G781 Stryker Spine was aware that there is a possible inability to insert the Cervicore Chisel guide over the fixation pin. It was discovered that the hole was too narrow to accommodate the fixation pin. A)All This action is being conducted for a labeling correction of the ZMR Porous Revision Hip B)All Prosthesis and ZMR Revision Taper Hip Prosthesis, including the indications for use, C)All contraindications, and warnings. Investigation has shown the potential for fracture of the D)All ZMR Revision Hip System where bone quality and bone quantity (especially in the proximal E)All location) and resultant proximal support is not optimal. The device indication will now be F)All limited to cementless revision hip arthroplasty. G)All H)All I)All J)All K)All
Cobas 4000 - Cobas C311 (stand alone configuration)
2011-11-28
2011-10-24 68254
Type II
4826876001
All the Software Versions
OBSERVA Database Management System
bioMrieux Inc.
2011-11-28
2011-10-12 68288
Type III
218039, 248027, 248029, 248035, 248036, 248043, 248055, 248056, 410461, 410462
N/A
Triathlon Slap Hammer CareFusion Avea Ventillators
Howmedica Osteonics Corporation CareFusion
2011-11-28 2011-11-28
2011-10-13 67749 2011-10-07 67761
Type II Type II
6541-4-803 Avea
CRZW01 > 100 Numbers, Contact Manufacturer
The manufacturer has identified during internal investigation, a software malfunction on the Cobas 4000/Cobas C311 Analyzer that could potentially lead to incorrect ISE test measurements. An anomaly with all versions of Observa has been identified that can cause positive and negative accessions to not be sent to the bottle lis. This anomaly can occur when results are received from the Bact/Alert 3D when Observa is running a scheduled bottle LIS link transmission and where the bottle LIS connection has been configured to send new test results. Complaints were received with regard to disfiguration of the plastic under-mold of the Triathlon Slap Hammer. Affected Avea Ventilators can over time develop a failure where the ventilator activates a false extended HIHG Ppeak alarm, opens the safety valve and stops ventilating. While the extended high Ppeak alarm is activated, by design, the safety valve OPS to ambienta air and allowing spontaneous breathing patients to continue breathing. Despite activation of the alarm under these circumstances, the paitent is not subjected to elevated airway pressures.
A) Biomet Arcom Patella Components B) Biomet Arcom Patella Components
Biomet Orthopaedics
2011-11-06
2011-10-06 67768
Type II
A) 184700, 184720, 184722 B) 184762, 184780, 184782 12-1130
Ambi Compression Hip Screw System - Standard Barrel Plates Smith & Nephew, Inc.
2011-11-28
2011-10-19 68305
Type II
A) 190350, 079520, 248190, 506170, 344670, 423400, 079530 B) 432450, 438780, 527760, 190440, 498310 10KT46884A
Labelling error identified on the external packaging of sizes 25 mm and 28 mm patella buttons indicating the devices as "for use with the Vanguard, Maxim, Ascent and AGC Knee System". These devices are not for use with the AGC Knee System. The 130 degree plate was marked incorrectly as 135 degree
Trilogy 200
Respironics Inc.
2011-11-28
2011-10-11 68381
Type II
CA1032800
TV211032405, TV211032409, TV211032412, TV211032413, TV211032414, RV211032415, TV211032419, TV211032420, TV211032430, TV211032431 > 100 Numbers, Contact Manufacturer
A small quantity of devices do not meet the minimum press-force required for assembling the impeller onto the motor shaft of the blower unit. The unit may be noisy or this may impact therapy up to the point of generating a device alarm or in the worst case could result in a blower failure causing the device to stop delivering therapy Wright Medical Technology has become aware of an issue relating to a label discrepancy that affects the shelf-life listed on the current Anchorlok Soft Tissue Anchor. The product functions as intended, however there is not adequate justification on file to support the 8 year packaging shelf life listed on the current label. This issue occurs because an older version of a non-clinical document can be displayed instead of the most recent version. Typically, the system displays the most recent version, and the user can select to view older versions from the history window. However, an older version of the document is displayed automatically when you do not select the older version or are aware that a newer version exists. There is a labelling issue with the 4C2223 Blood Component Infustion Set in which the package label incorrectly states 80 micron filter when the actual filter is a standard blood filter of 170-260 micons in size. In instances where the pump alarms for accumulated air in line and detects froth in quick sucession, the infusion will stop as desired, but a malfunction might occur where the pump will stop operating. Product from Lot 020 is not authorized for sale in Canada and was accidentally sent to customers. Customers should have received Lot 018. The design of the Ultralite Mark II model relies on the cable adapter that is is assembled through the headlight body top into the lens cell top, to hold the headlight in place and prevent the headlight from falling off. If the cable adapter becomes loose there is a potential that the headlight assembly can become separated from the headband assembly and drop into the patient wound site. During the patient transfer from a stretcher to the catheterization table, unexpected tabletop rotation occurs if the tabletop is not positioned in its foot-end, or there is not enough assistance while transferring the patient to the catheterization table. When excessive force is added to the tabletop, it may rotate unexpectedly. Ortho Clinical Diagnostics (OCD) has received several complaints regarding quality control fluid results that are below the measuring (reportable or dynamic) range for generation (GEN) 72 of Vitros chemistry products NBIL DT slides when calibrated with Vitros chemistry products DT Calibrator Kit Lots 37 and 38. Steris Corporation has learned that a limited quantity of hydraulic column cylinders installed into certain 5085 and 5085SRT Surgical Tables were assembled by the supplier with incorrect snap rings and an anomaly in the tilt cylinder. These conditions may affect the flow of hydraulic oil through the tilt cylinder and have the potential to affect the user's ability to move the table top out of the full right tilt position. Abbott Medical Optics Inc. initiated this event after becoming aware of a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 micrometres or deeper) created using the femtosecond laser system. This discrepancy between the user-set depth of corneal tissue incision and the actual depth of those incisions was discovered during an engineering investigation conducted prior to the launch outside the united states of a new indication for arcuate incision procedures. The engineering investigation was not initiated due to the receipt of a complaint. Ortho Clinical Diagnostics (OCD) has received complaints of lower than expected results for control fluids and patient samples upon initial calibration or following recalibration using Vitros Chemistry Products Calibrator Kit 24 and Vitros Chemistry Products Malb Reagent. All current lots of Vitros Calibrator Kit 24 may experience a change in performance over time, which will yield lower than expected results when they are used to calibrate all current Gens of Vitros Malb Reagent. Depuy Mitek is initiating a recall of a specific lot of Lupine Loop Anchor because of a manufacturing assembly issue. The lot was assembled with an incorrect suture configuration. If the incorrect suture configuration goes undetected it could result in a loose repair. When used in a clinical environment, the Curix Opthos H Film described above, "flipped" or "reversed" , loaded in a Curix Opthos H Asymmetric screens and cassette and exposed as normal, may be viewed to have slightly different image quality than the expected normal Curix Opthos H image quality. Colgate-Palmolive Canada Inc. is initiating a recall of Colgate Motion and Colgate Motion Whitening battery toothbrushes due to a small number of reports received involving rapid gas venting of the battery which may cause the battery cap to suddenly burst from the unit resulting in a loud noise. There have been no serious injuries resulting from the reported events. The Brainscan Pencil Beam dose algorithm may overestimate the dose delivered to the targeted region if certain conditions are met. As a consequence, doses lower than planned might be delivered to the patient, potentially resulting in ineffective treatment. The manufacturer has confirmed that a limited number of units from specific product code / Lot number combinations of the Encor Biopsy Probes may have packaging damage resulting from transportation. The packaging damage ranges from broken trays to visual cosmetic defects of the trays. Loss of communication between the wireless processing unit and the display controller unit may cause unprompted changes to alarm high and low limit values and to the units of measure for some parameters. A small number of failures (0.85%) have been reported where components have cracked unexpectedly, both at the fitting stage and after a period of use. Similar failures could result in the limb wearer falling and injuring themselves.
Anchorlok Soft Tissue Anchor System
Wright Medical Technology Inc.
2011-11-28
2011-11-03 68581
Type II
5100-0002, 5100-0004, 5100-0006, 5100-0008, 5100-0010, 5100-0012, 51000014, 5100-0016, 5100-0018
Cerner ProVision Document Imaging
Cerner Corp.
2011-11-28
2011-09-14 67343
Type II
N/A
Imaging 2007.18 35863, Imaging 2007.09 38896, Imaging 2010.01 41919, Imaging 2010.02 45389 > 10 Numbers, Contact Manufacturer
Blood Administration Set
Fenwal, Inc.
2011-11-28
2011-10-07 67763
Type II
4C2223
Symbiq Infuser
Hospira Inc.
2011-11-28
2011-10-17 68256
Type II
16026, 16027
N/A
Advia Centaur XP HUV AG/AB Combo (Chiv) Assay Luxtec Ultralite Pro Headlight
Siemens Healthcare Diagnostics Inc. Integra Burlington MA, Inc.
2011-11-28 2011-11-28
2011-10-28 68460 2011-10-14 67766
Type III Type III
6520528 N/A
20 AX2000BIF, AX2100BIF, AX1375BIF, AX1385BIF, 1380LX, 1328
Catheterization Table
2011-11-28
2011-10-01 68228
Type II
CAT-850B
> 10 Numbers, Contact Manufacturer
VITROS Chemistry Products DT Calibrator Kit
2011-11-28
2011-10-14 68304
Type III
N/A
37, 38
A) Steris 5085 Surgical Table B) Steris 5085SRT Surgical Table
Steris Corporation
2011-11-28
2011-10-17 68312
Type III
A) ST014101 B) ST014101
A) N/A B) N/A
A) Intralase FS Laser B) IFS Advanced Femtosecond Laser
AMO Manufacturing USA, LLC.
2011-11-28
2011-10-27 68461
Type II
A) FS, Model 2 B) Model IFS
A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer
VITROS Chemistry Products Calibrator Kit 24
2011-11-28
2011-10-28 68645
Type III
6801708
All
Lupine BR Anchor with Orthocord
Depuy Mitek
2011-11-28
2011-11-01 68691
Type II
210711
3549273
Curix Opthos H 35x43cm, NIF
Agfa Corporation
2011-11-28
2011-10-07 67769
Type III
35HJQ
79890049
Colgate Motion Electric Toothbrush
Colgate - Palmolive Canada Inc.
2011-11-28
2011-11-03 68604
Type III
Colgate Motion, Colgate Motion Whitening
Brainscan Platform Software
BrainLab AG
2011-11-28
2011-11-07 68664
Type II
20140A, 20140B, 20140C, 70140, 70151C
N/A
Bard Encor Biopsy Probes
Senorx Inc.
2011-11-28
2011-11-09 68766
Type II
ECP01-10G, ECP01-10GV, ECP01-12G, ECP01-12GV, ECP01-7G, ECP01-7GV, ECPMR01-10G
3160 MRI Patient Monitoring System (Precess Unit)
Invivo Corporation
2011-11-28
2011-09-23 68277
Type II
3160DCU (865112), 3160WPU (865113)
00475 (3160DCU), 0000A30765 (3160DCU), 0000A30766 (3160DCU), 0000A30771 (3160DCU), 0000A30765 (3160WPU), 0000A30766 (3160WPU) P265 to P365, Q001 to Q365, R001 to R365, S001 to S365, T001 to T048
Endolite 30mm Pyramid Clamp Adaptors
Blatchford Products Ltd.
2011-11-28
2011-08-08 68508
Type III
409028, 409054
A) Broselow/Hinkle Pediatric Emergency System Kit Vital Signs Inc. B) Broselow/Hinkle Pediatric Emergency System Flying Carpet C) Broselow/Hinkle Pediatric Emergency System IV Module D) Broselow/Hinkle Pediatric Emergency System Intubation Module E) Broselow/Hinkle Pediatric Emergency System Intraosseous Module F) Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Module G) Broselow/Hinkle Pediatric Emergency System Pouch, Bag and Tag Pack
2011-11-28
2011-09-27 67377
Type II
A) 7730AL, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5 B) 7730FLY C) 7700BIV2, 7700GIV2, 7700OIV2, 7700PIV2, 7700RIV2, 7700WIV2, 7700YIV2 D) 7700RIN2 E) 7700RIO2 F) 7700RAW2 G) 7730POCH
A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer C) > 10 Numbers, Contact Manufacturer D) > 10 Numbers, Contact Manufacturer E) > 10 Numbers, Contact Manufacturer F) > 10 Numbers, Contact Manufacturer G) > 10 Numbers, Contact Manufacturer
Vital Signs Devices, a GE Healthcare company has become aware of a safety issue associated with Povidone Iodine Pad included in the Vital Signs Broselow Pediatric Emergency System Kit. The manufacturer of the Povidone Iodine Pad, H&P Industries, is conducting a field corrective action to address a potential contamination of these products with an objectionable organism, Elizabeth Kinga MeningoSeptica.
Enflow IV Fluid Warmer
Enginivity LLC
2011-11-28
2011-11-09 68642
Type II
980100, 980105VS
> 10 Numbers, Contact Manufacturer, > 10 Numros, Contactez Fabriquant
Vancomycin Calibrators
Seradyn Inc.
2011-11-28
2011-11-01 68675
Type III
196076
Unknown
Premier EHEC
Meridien BioScience Inc.
2011-11-28
2011-10-12 67996
Type III
608096
608096B149, 608096B151
APB Monitor
Spacelabs Healthcare Ltd.
2011-11-28
2011-11-01 68677
Type III
90217A
Ligasure Dolphin Tip Sealer/Divider
Covidien LLC
2011-11-28
2011-11-10 68841
Type I
LS1500, LS1520
Softbank II V.23.2/25.0/25.1
SCC Soft Computer
2011-12-12
2011-09-16 68455
Type II
V.23.2, V.25.0, V.25.1
217A-000780, 217A-000872, 217A-000018, 217A-000026, 217A-000133, 217A-000134, 217A-000181, 217A-000195, 217A-000204 Model# LS1500: Lots S1CB001 through S1JB048X, Model# LS1520: Lots S1CB010X through S1HB013P All Lots
Delta Q Sterilizer D-Spect Cardiac Scanner System
Pelton and Crane Spectrum Dynamics (Israel) Ltd.
2011-12-12 2011-12-12
2011-10-31 68810 2011-07-18 68848
Type III Type III
054200, AF N/A
S/N 20182 N/A
Vitros Chemistry Calibration Kit 16
2011-12-12
2011-11-11 68859
Type III
6801700
1630
GE Healthcare has become aware, through customer complaints, of a safety issue associated with Enflow IV fluid warmer. There is an issue that can result in an excessive external surface temperature on the underside of the enflow warmer which can result in potential burns to patients or clinicians who touch the device. Microgenics / ThermoFisher has confirmed an average shift in results of approximately +22.6% when using the Vancomycin Calibrator Lot #59391741 (expiry date December 31, 2011). Microgenics / ThermoFisher investigation is underway to determine root cause and determine correction for future Lots. Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurence will likely impact clinical sensitivity as defined by product registration and associated instructions for use. Reports of abp recorders showing an EC75 error code and ceasing to function. When this happens the power must be cycled off and on to restore functionality. No one has been injured as a result of this issue. The recall is being conducted due to the potential for the handle pins to disengage which could compromise handle unlatching. This may complicate removal of the device jaws from targeted tissue. In an open procedure, there is a risk that the disengaged handle pin may fall into the patient cavity and go unnoticed. When printing an ISBT label for blood product with an expiration time of midnight (00:00), the generated label prints 23:59 instead as the expiration time in the barcode. The unit can be mislabeled with a falsely extended expiration time. The front panel had missing segments on the display panel because not all display segments were illuminating properly. During routine operations, the detectors housing is manipulated for best positioning. If the detector head is pulled or pushed aggressively and repeatedly, this type of handling might result in extreme cases, the detector head to slide out from the gantry. In this case possible damage to the system or contacting with patient's legs might occur. Ortho Clinical Diagnostics (OCD) was notified by its supplier that lot 1630 of Calibration Kit 16 would not meet its specified 12-month stability. OCD testing indicates that patient results generated using Vitros Chemistry Products RF reagent calibrated with Vitros Calibrator Kit 16, Lot 1630 may demonstrate a positive bias across the measuring range of 8.6-120 iu/ml if a new calibration is performed. The positive bias is readily identifiable by routine postcalibration quality control testing with control fluids. To date, OCD has not received any complaints related to this issue. In some Aquilion 64 Systems, the Dose Length Product (DLP) Value is displayed incorrectly when the optional Variable Helical Pitch (VHP) is used. Possible elevated recovery in patient samples observed with the Cobas Integra Theophylline for the Hitachi/Modular P Theophylline of Lot No. 65122701 Certain lots of the affected lenses did not meet the new manufacturing acceptance limit for the presence of residue (Silicone oil) which may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment. It has been determined that some drive stand bolts may fail to meet mechanical specifications. These load - bearing stand bolts are used to secure the drive stand assembly to the base frame. Failure of some of the gantry stand rear bolts may lead to a shift of the linear accelerator isocenter. The affected bolts were isolated to a single lot of bolts supplied to Varian. The radiopaque segment may detach during in vivo use resulting in device fragments that will remain in the patient's vasculature.
Aquilion 64 System A) Hitachi and Modular P Theophylline B) Cobas Integra Theophylline for Cobas C Systems A) Encore 100 Sphere B) MediFlex Aquafinity 125 C) 2 Clear Comfort Truebeam (Radiotherapy Configuration)
Toshiba Medical Systems Corporation Roche Diagnostics GMBH Coopervison Inc.
2011-12-12 2011-12-12 2011-12-12
2011-10-27 68829 2011-11-03 68877 2011-11-17 68974
Type III Type III Type I
TSX-101A/H, TSX-101A/HX A) 03800474190 B) 04491025190 A) Encore100 Sphere B) MediFlex Aquafinity 125 C) 2 Clear Comfort N/A
S/N: HCB0993654, HCB1023752, HCB10X3839 A) 65122701 B) 65123301 A) Contact Manufacturer B) Contact Manufacturer C) Contact Manufacturer H191038
2011-12-12
2011-05-13 69035
Type II
A) Safesheath CSG Hemostatic Introducer B) Safesheath Lateral Vein Introducer
Thomas Medical Products, a GE Healthcare Company
2011-12-12
2011-10-07 68375
Type I
A) CSG/WORLEY/BCOR-1-09, CSG/WORLEY/BCOR-2-09, A) >10 Numbers, Contact Manufacturer CSG/WORLEY/L/BCOR-1-09 B) >10 Numbers, Contact Manufacturer B) LVI/75-5-62-07-HS, LVI/75-5-62-07-MP, LVI/75-5-62-07-RE, LVI/TELE/B-60-07HO, LVI/TELE/B-60-07-MP, LVI/TELE/B-60-07-RE
Digital Diagnost
2011-12-12
2011-11-04 68644
Type II
9890-010-83903
N/A
Expression MRI Patient Monitoring System-Main Unit
Invivo Corporation
2011-12-12
2011-11-02 68680
Type II
865214
N/A
Outlook 621-ES100
B. Braun Medical Inc.
2011-12-12
2011-08-26 68771
Type II
621-100ES, 621-200ES, 621-300ES, 621-400ES
A) Custom Sterile Cataract Pack B) Sterile Eye Custom Pack C) Custom Eye Preparation Pack D) Eye Pack E) Day Surgery Pack F) Cartoid Pack G) Custom Sterile Plastics Pack
Cardinal Health
2011-12-12
2011-11-07 68861
Type II
A) 027037, 031646, 046301, 027665, 042484, 046654 B) 034330, 041614 C) 030707, 040090 D) 030220, 032852, 045786, 026659, 043922 E) 033349 F) 030076 G) 025031, 0253031
Potential for a small metal protective cover on the bottom side of the control handle for the ceiling suspension is missing. This exposes electrically live parts on the printed circuit board of the control handle to the potential for direct contact. The live voltage is small (25 volts) but is a deviation from the IEC Standard 60601-1. Over time, it may be possible for all six nuts securing the dcu to the cart may become disengaged from the DCU docking plate. As a result, a docked dci may become unbalanced and fall off the cart during transport or during tilting of the docked DCU. The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state when a sequence of hold-hold key strokes are performed on the pump key panel. The recall was initiated due to the possibility that a small percentage (approx 1.5%) of the BD 30g needles (catalog 300745, lot 1116090) contained in Cardinal Health Custom Sterile Packs may be clogged.
Alaris PC Model 8015
CareFusion 303 Inc.
2011-12-12
2011-11-02 69106
Type II
TC10005122
N/A
A problem with the power supply board used with the Alaris PC Unit Model 8015 only. A component on this power supply board is drawing extra charge and depleting the battery sooner than expected. The initial low battery message/ alarm will indicate that the battery has less than 30 minutes before depletion. However the battery power may not be available for the time indicated. If an affected power supply board is used in a PC Unit the battery may not last as indicated by the low battery message/alarm. If the PC Unit is not plugged into an A/C outlet as soon as the low battery message appears, this could stop infusion or delay therapy which may result in serious injury and/or death. Stryker orthopedics has identified an issue whereby an incorrect laser mark was noted on specific lots of the product. The stems read "t#9stm-30nk" but should read "t8stm-30nk". This error incorrectly implies the stem is a size #9, when the stem is actually size #8. Potential hazard associated with the use of pdi alcohol prep pads. These non-sterile alcohol prep pads are included in Spacelabs Healthcare Hook-up kits and may have the presence of a bacterium, bacillus cereus, which could lead to life-threatening infections. Issue with Mosaiq that could affect any treatment field defined with MLC leaves at the time of RTP import of treatment plans. A product defect truncates the MLC leaf values upon the import of a treatment plan after the 3D image viewer has been opened, if the workstation on which the import was executed is configured to use a comma(,) as the decimal separator. This involves sequencer for Mosaiq 2.20.08 (first build released May 2011) including all released builds and service packs of version and version 2.00x3sp6 (first build released Sept 2011). A possible software bug of the Accu-Check Inform II Meters with Software Versions 03.02.01 or 03.03.00 when configured to allow the operators to add new patient IDs. A small percentage of the implants may not have the internal thread which is necessary to assemble mating components. The weight-based drug dosage calculation may deliver incorrect recommendation values if the patient's body weight is not entered via the Admin-/Demographics screen, but entered via the Drug Dosage application screen. One hospital in Germany also reported a misalignment of ECG and Art Waveforms delivered from this product. Numed canada inc. incorrectly labeled 9 catheters. 3 units are still in inventory at numed canada and 6 units were shipped with the wrong lot number prefix on the box label. The elastic bands on the Neuro Elastic Retractors are breaking within the sealed packaging or during use prior to their expiration date.
Osteonics Restoration Hip System - Reduced Neck Hip Stem - HowMedica Osteonics Corporation Straight
2011-12-12
2011-10-31 68646
Type II
S-2653-0812L/R
N/A
A) Evo 4 Electrode Hookup Kit B) Aria Hookup Kit C) Lifecard Holter Hookup Kit Sequencer
SapceLabs Healthcare Ltd.
2011-12-12
2011-10-21 68681
Type II
Elekta Business Area Software Systems Impac Medical Systems, Inc.
2011-12-12
2011-11-02 68776
Type II
A) 50-0048, 50-0049 B) 23189-106 C) 23189-116 N/A
A) B33973 B) B33901, B33905 C) B33901, B33905 N/A
A) Accu-Check Inform II Meter B) Accu-Check Inform II + RF Meter Osseotite Certain Implant Infinity Acute Care System (IACS) Monitoring Solution
2011-12-12
2011-11-04 68793
Type II
A) 05060311001 B) 05060303001 IOSM313 MS25520
A) Software Versions 03.03.01 AND 03.03.00 B) Software Versions 03.03.01 AND 03.03.00 2010111529 5610224874
Biomet 3I (also Trading as Implant Innovations, Inc.) Draeger Medical GMBH
2011-12-12 2011-12-12
2011-10-11 68806 2011-10-11 68064
Type III Type I
Nucleus-X Catheters A) DuraHook Scalp Retractor B) DermaHook Skin Retractor
Numed Canada Inc. Teleflex Canada
2011-12-12 2011-12-12
2011-10-20 68643 2011-11-21 69006
Type III Type II
PVN409 A) 382800 B) 382805
YX-0053, YX-0054 A) >10 Numbers, Contact Manufacturer B) 01E1000026, 01A1100370, 01G1000251, 01H1000296, 01J1000298, 01K1000051, 01L1000282, 01M1000199, 01M1000200 All Affected XVI 4.5
Synergy XVI
Elekta Limited
2011-12-12
2011-10-14 68287
Type II
MRT14921
If you make a correction where you move the Clip/Mask slider in the Clipbox, it can move the critical structures in an incorrect direction. This only occurs if there is a large rotation in the Clipbox registration. Elekta recommends to do an image review to make sure that the end result is correct. If error not seen and treatment table correction has been applied, it can cause clinical mistreatment. May cause reduced V-Lyte integrated multisensor on-board use life as demonstrated by increases in urine QC sodium results within 48 hours after installation of a new IMT sensor. The QC results can be elevated approximately 10-20% which results in urine QC results rising out of acceptable QC ranges. It was detected in QC control that the hole used to thread the Solis Trial onto the implant holder was manufactured on the left side of the instrument instead of the right as indicated on the engineering print. This leads to the trial being placed upside down on the handle. The implant handle has markings indicating the cranial and caudal sides on the top and bottom respectively. The nonconforming trials result in the cranial side of the trial being inserted facing caudal. A manufacturing issue has been identified that may result in the distal tip of the outer sheath (return electrode) detaching and becoming loose in the joint during use. Synthes (Canada), Ltd. Is initiating a medical device recall for the drill bit due to the potential for the drill stop to slip on the reamer. If the drill stop slips on the reamer, it may cause deeper reaming than intended, and in rare cases, penetration of the joint space causing pain and/or joint irritation.
Dimension Vista System- V-Lyte Integrated Multisensor Na K Cl
2011-12-12
2011-11-02 68678
Type III
K820, K825, K835
KA1G01, KA1H01, KA1J01, KB1G02, KB1J01, KB1K01, KE1H01, KE1J01, KE1K01
Solis Trial Cage
Stryker Spine SAS
2011-12-12
2011-11-07 68821
Type III
8741206, 8741207, 8741209, 8741404, 8741406
91854, 10G655, 10G757, 10F956, 08C688
Dyonics Electroblade Resector - Full Radius
2011-12-12
2011-11-07 68862
Type I
7205962
897191, 868519, 868509, 863004, 830569, 830568 All Lots / Tous les Lots
Drill Bit
Synthes (Canada) Ltd.
2011-12-12
2011-11-14 69107
Type II
03.010.228
SPOT-Light HER2 CISH Kit
Life Technologies Corporation
2011-12-12
2011-10-19 69187
Type II
84-0150
Lot 1029335
It was determined that lot number 1029335 of SPOT-Light Her2 CISH Kit includes Reagent H that may be contaminated with lecanicillium fungicola, a fungal contaminate. Stryker was aware of a higher risk of tip breaks for the Serfas Energy Probe. Issue #1 (Volume Viewer): on monitors with 2 megapixel (2MP) resolution and higher (i.e. higher than 1600x1200 resolution), for a certain sequence of user commands, switching between two Volume Viewer tabs with different patients, the topmost strip of the Volume Viewer display fails to update between patients. This causes the incorrect (i.e., first) patient name to display in the topmost viewports when the second patient's image data is displayed. The lower viewports display the correct patient name, as does the patient name tab. Issue #2 (Results Viewer): on AW Server, the results viewer application may take 5-8 seconds to initialize and display a selected patient exam when first started. If a second patient exam is selected before this initialization has completed, the second patient's data will be displayed in the viewports with the corresponding patient name on the viewports. However, the first patient's name will be displayed on the applications tab. A recent modification of the BIS Bilateral Sensor reversed the reference electrode and the left eye electrode. This change will result in the inaccurate calculation and presentation of processed Electroencefalography(EEG) information for Bispectral Index (BIS), Density Spectral Array(DSA) and Asymmetry (ASYM) values.
3.5mm Super 90-S Serfas Energy Probe AW Server
Stryker Endoscopy GE Emdical Systems, LLC
2011-12-12 2011-12-12
2011-10-31 68647 2011-11-25 68684
Type II Type II
0279-351-300 5317169-X
11161AE2 to 11241AE2 >10 Numbers, Contact Manufacturer
BIS Bilateral Sensor
Covidien LLC
2011-12-12
2011-11-09 69209
Type I
186-0212
0607111A
Super Torque MB Angiographic Catheter
Cordis Corporation
2011-12-12
2011-11-25 69239
Type II
532-598A, 532-598B, 532-598C, 532-598D
15435050, 15402631, 15257142, 15247189, 15206620, 13431281, 15277504, 13460575, 13467459 A) 5398255564, 5398293656, 5398294156, 5398294254, 5398294949, 5398754355 B) >10 Numbers, Contact Manufacturer C) >100 Numbers, Contact Manufacturer 9891JEU00024 - 2001-98JEU00195, 010824 100930
Cordis has issued a Field Safety Notice to provide important information concerning a potential for marker band dislodgement in the Super Torque MB Angiographic Catheter during endovascular procedures when the catheter is stretched or elongated, and important recommendations for clinical use. Ventricular fibrillation (VFIB) arrhythmias may not be recognized by the monitor and may not alarm when the Masimo Set Pod is used for SPO measurements.
A) Gamma XXL B) Delta Monitor C) Delta XL Monitor
Draeger Medical Systems, Inc.
2011-12-28
2011-10-25 68425
Type II
A) MS18852 B) MS18597 C) MS18596
Infant Radiant Warmers
Fisher and Paykel Healthcare Ltd.
2011-12-28
2011-11-11 68668
Type II
IW910, IW920, IW930, IW931, IW932, IW933, IW934, IW950, IW951, IW952, IW953, IW954, IW960, IW970, IW980, IW990
A) Bivona Tracheostomy Tubes TTS - Pediatric/Neonatal B) Bivona Tracheostomy Tubes Flex-Tend - Pediatric C) Bivona Tracheostomy Tubes Aire-Cuf - Pediatric/Neonatal
Smiths Mdical ASD Inc.
2011-12-28
2011-11-29 69167
Type II
XVI R4.5 (X-Ray Volume Imaging System)
Elekta Limited
2011-12-28
2011-10-20 69207
Type II
A) 67N025, 67N030, 67N035, 67N040, 67P030, 67P035, 67P040, 67P045, 67P050, 67P055 B) 60PFP40, 60PFP45, 60PFS30, 60PFS40, 60PFS50, 60PFSS45 C) 60N025, 60N035, 60N040, 60NFP25, 60NFP30, 60NFP35, 60NFP40, 65P025, 60P030, 60P035, 60P040, 60P045, 60P050, 60P055, 65P025, 65P030, 65P035, 65P040, 65P045, 65P050, 65P055 MRT14921
A) 1631477 - 1923406 B) 1631477 - 1923406 C) 1631477 - 1923406
G28421 - G35174
Tomotherapy Shareplan 1.1 Acrobat V Vacuum Stabilizer System
Raysearch Laboratories Maquet Cardiovascular LLC
2011-12-28 2011-12-28
2011-10-10 68876 2011-11-24 69278
Type III Type II
1.3.1.10 OM-9100S
S/N 1.3.1.10 25040646
The movement of the warmer head can put stress on the head harness connector. Prolonged exposure to this stress can lead to electrical arcing at the connector which may lead to discolouration, occasionally charring of the electrical connector or it can lead to a loss of electrical power to the heating element. Smiths Medical has become aware of a small number of complaints of customers experiencing difficulty disconnecting accessories from the connectors of the affected tubes. In some cases, the customer was unable to disconnect the accessory or excessive force lead to decannulation of the tube, and an emergency tracheostomy tube change was required. If the accessory is correctly connected to the affected tubes, then there will be no issue with disconnection. A small number of sites have experienced situations with KV Generator Transformers overheating due to a diode failure on the interface board. If it occurs, it can cause non-toxic smoke and small fires in the KV Generator. As this fault occurs inside the generator, in the equipment room, the risk of injury to patients or hospital personnel is very small. Behaviour of the Shareplan may be unexpected and not cleary described in the user manual. As a result of product quality monitoring, it was brought to our attention that there might be a small perforation in the sterile pouch of these products. An investigation revealed this small perforation potentially occurring due to manufacturing related causes. As a result, there is a potential for the pouch integrity to be compromised, which may result in compromised sterility of the product. The patient risk is that if the compromised product is used in surgery it may result in an increased chance of infection for the patient. The hemostasis sidearm assemblies have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. If the flash found at the base of the housing of the hemostasis valve were to break off and enter the fluid path of the product, it could potentially be flushed into the patient's venous system. This condition would not be obvious to the end user. The product code etched onto the outer box of the above named product contains a typographical error. The code reads "APR2-10" instead of "ARP2-10". The product code on the immediate product container (Vial) is accurate, as is all other labelling accompanying the product. The CD2 Assay value assigned for the affected kits is incorrect, and may cause a delay in the ability to report CD2 values if the control values are out of the assigned range. The Visum LED Surgical Lights are intended to illuminate operative sites during surgical procedures with high intensity light. Stryker's analysis has revealed that it is possible for the Visum LED Surgical Light to separate from the arm. Philips has become aware that when the user changes the machine for step and shoot beams from a fixed jaw to a variable jaw machine, the jaws may change from symmetry to asymmetry to duplicate the original beam, but the jaw symmetry yes/no option remains set to yes. When exported via Dicom RT, the Multileaf Collimeter (MLC) and jaw positions agree with the Pinnacle Plan. However, because the Jaw Symmetry Flag is set to yes, the Record and Verify (R&V) system may force the jaws to be symmetric, thereby re-positioning the beam. The resulting beam on the R&V side does not match the beam in Pinnacle. Issue relating to Detector Buckets that may experience weakness over time. This could cause the Detector Bucket to separate from the mounting plate of the Gantry and could eventually result in the Detector falling.
VenaCure EVLT NeverTouch Procedure Kits
Angiodynamics Inc.
2011-12-28
2011-11-11 69279
Type I
11403001, 11403003
549607, 549609, 552940
Cryocheck Abnormal 2 Reference Control
Precision Biologic Inc.
2011-12-28
2011-11-29 69302
Type III
ARP2-10
9054
Coulter Cyto-Trol Control Cells Kit Visum LED Surgical Light
Beckman Coulter, Inc. Stryker Communications
2011-12-28 2011-12-28
2011-10-17 68310 2011-11-09 68822
Type II Type II
6604248 0682-001-252, 0682-001-253, 0682-400-137, 0682-400-138
7319028K, 7319029K, 7319030K, 7319031K 0682-001-252, 0682-001-253, 0682-400-137, 0682-400-138 N/A
Pinnacle 3 Radiation Therapy Planning System-SmartArc Module
2011-12-28
2011-11-17 69142
Type II
4535 604 46041
A) Axis Variable-Angle Dual-Detector Gamma Camera B) Irix Variable Angle Nuclear Imaging System C) Axis Gantrys D) Irix Gantry E) Irix Triple Detector Camera 150ml Burette Set
2011-12-28
2011-11-17 69143
Type II
Hospira Inc.
2011-12-28
2011-11-14 68808
Type II
A) N210623, N211037, N211039 B) N210856, N210879, N211038 C) N211280 D) N211281 E) N211040 19208
A) N/A B) N/A C) N/A D) N/A E) N/A 831075H
A) Access Ostase Assay Reagents B) Access Ostase Calibrators C) Access Ostase QC A) AMH Gen II ELISA B) AMH Gen II Calibrators and Controls Vitrea 2
2011-12-28
2011-11-07 68857
Type II
Beckman Coulter, Inc. Vital Images, Inc.
2011-12-28 2011-12-28
2011-11-07 68858 2011-11-11 69160
Type III Type II
A) 37300 B) 37305 C) 37309 A) A79765 B) A79766 VPMC-11906, VPMC-11907, VPMC-11908, VPMC-11909, VPMC-11910, VPMC11911, VPMC-12018, VPMC-12020, VPMC-12021, VPMC-12022, VPMC-12023 8367-20, 8367-40
A) 011167, 014486, 017561 B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer A) All B) All Vitrea Enterprise Suites 6.0, Vitrea Enterprise Suites 6.1 Contact Manufacturer, Contactez Fabriquant >10 Numbers, Contact Manufacturer
The potential for the Float Valve (Automatic Shut-off Valve) to stick to the Burette and therefore not open properly. If the Float Valve sticks,the Burette port will remain open after administration of fluids. Affected Access Ostase Calibrator and QC Lots do not meet expiration date claims. As a result, Quality Control and Patient Sample results may be falsely elevated by up to 14%. The Linear Curve Fit option is not an appropriate statistical model for the AMH Gen II ELISA Assay. The calibrators may show a non-linear response. Two issues have been identified that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This field action is a follow-up to Medtronic customer notification regarding Synchromed II Model 8637. Medtronic is now exchanging non-implanted Synchromed II Pumps containing the original design batteries with pumps containing the new batteries. Smiths Medical has become aware of an increased trend in reports of disconnections of the Luer lock connector at the patient end of the tubing on certain sets. If the Luer lock connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in therapy, which could result in patient injury or, while highly unlikely, death. Smiths Medical has become aware of an increased trend in reports of disconnections of the Luer lock connector at the patient end of the tubing on certain sets. If the Luer lock connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in therapy, which could result in patient injury or, while highly unlikely, death. A small percentage of units shipped from August 2010 - November 2010 could have a crack on the bottom of the sample site, which could result in a small amount of leakage of intravenous fluids or blood. Change in reconstituted stability of papp-a standards/calibrators.
Medtronic SynchroMed II Implantable Programmable Drug Pump Level 1 Normothermic IV Fluid Administration Sets
Medtronic Inc.
2011-12-28
2011-11-23 69281
Type II
2011-12-28
2011-11-28 69398
Type II
D-60HL, DI-60HL
HOTLINE Blood and IV Fluid Warming Sets
2011-12-28
2011-11-28 69399
Type II
L-70, L-70NI, L-80
Venous Arterial Blood Management System (VAMP)
Edwards LifeSciences LLC
2011-12-28
2011-01-28 66473
Type II
48VMP120, PXVMP120, PXVMP160, PXVMP172, PXVMP260, PXVMP272, PXVMP3X32, PXVP0568, PXVP2260, PXVP2284, PXVP23X3, VMP106 A) B098-201 B) 6003-0020 DR-XD-200G
A) 1235 Autodelfia System - PAPP-A B) Delfia Xpress 6000 Immunoanalyzer System - PAPP-A Assay System Fujifilm FDR Acselerate
Wallac OY
2011-12-28
2011-11-08 68863
Type II
Fujifilm Corporation
2011-12-28
2011-10-11 69104
Type II
A) 610717, 610931, 612004, 612648 B) 609917, 610229, 610752, 610915, 611438, 611611, 612155, 612439 5051
When switching exposure menus too quickly in the Dr Operator's console, the X-ray console may only display the settings of a previous exposure menu, thus introducing the possibility of delivering an incorrect exposure to a patient, or it may freeze.
Dimension Vista Cardiac Troponin I Calibrator
2011-12-28
2011-11-17 69169
Type III
KC678
1DD085
Hospital Bed Electrosurgical Unit
Revolution Sante (FASRS) 9191-6445 Qubec Inc. Celon AG Medical Instruments
2011-12-28 2011-12-28
2011-04-11 69293 2011-11-30 69527
Type III Type II
RS508 ESG-100
N/A 25456W23-101, 25456W23-103, 25456W23104, 25456W23-105, 25456W23-109, 25456W23-110, 26879W23-101, 26917W23104, 25456W23-106
A) Coulter LH 780 Analzyer B) Coulter LH750 Analyzer C) Coulter LH500 Analyzer Compat Enteral Delivery Sets
2011-12-28
2011-11-28 69528
Type II
Nestle Healthcare Nutrition Inc.
2011-12-28
2011-11-30 68865
Type III
A) 723585 B) 6605632 C) 178832, 178833, 178834 N/A
A) All B) All C) All 9519810, 9519805, 9521433, 9521434, 9522610, 9521429, 9521430 A) N/A B) N/A All
A) AW Volumeshare 2 with Functool Application B) AW Volumeshare 4 with Functool Application Elecsys Digoxin
2011-12-28
2011-12-08 69654
Type III
A) 5183685-X B) 5342425-X 11820796322
2011-12-28
2011-12-08 69662
Type III
Siemens Healthcare Diagnostics have received customer inquiries for QC and patient shifts following calibration with lot 1DD085. Internal testing has confirmed shifts with some calibrator sets from this lot. Operations has tested one set of 1DD085 from six shipments from the American Distribution Centre (ADC) in Indianapolis, Indiana to Glasgow, Delaware and found two sets to recover within 3% of nominal, two sets to recover 3-5% below nominal, and two sets to recover 5-7% below nominal. Calibrator sets recovering below nominal will cause qc and patients to shift high. A patient shift of up to 26% may occur at 0.04 ng/ml which could change a sample to 0.05 ng/ml which is above the 99th percentile upper reference interval (0.045 ng/ml). The half bed rail jammed with the spring when lowered, which prevented it from being lowered smoothly and quietly. Olympus Canada Inc. (OCI) has initiated this recall following complaints received outside of Canada associated with inconsistent or failed electrical output from the ESG-100. Investigation of the customer complaints has revealed two capacitors mounted on the main board of certain ESG-100 may be counterfeit components. Performance testing on ESG100s with counterfeit capacitors satisfied the established release specifications for this product, but the performance of the counterfeit capacitors can degrade over time. The Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls Assay Sheets using the 2D Barcode scanner. Nestle Health Science determined that drip chamber material in select codes of Compat Enteral Feeding Administration sets produced prior to August 2009 may have caused slipoff occurrences. GE Healthcare has become aware that the Functool Application version 9.4.04B has an issue that prevents "Function Application" from loading more than two series. The affected Functool Software version was included in the previous GE Recalls. The product will have its corresponding instruction for use document updated in section "Limitation - interference". Among the list of pharmaceuticals causing falsely elevated digoxin values at concentrations of the recommended daily dose, nabumetone and pentoxifylline were re-added and triamterene was removed. Nabumetone and pentoxifylline are not new limitations. They were accidentally removed since last edition in June 2010.

MD Recalls 2011-Eng

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MD Recalls 2011-Eng

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MEDICAL DEVICES RECALL LISTINGS: 2011

Recall Start Date

Reason for Recall

Datex-Ohmeda, Inc. DBA GE Healthcare

Beckman Coulter, Inc.

GE Medical Systems LLC

Beckman Coulter, Inc. Cardinal Health

2010-11-08 59044 2010-11-16 59306

33500, 33505 250FPRL

All lots 2015-07-08

A) Mevatron Linear Accelerator B) Oncor Impression 3D Plus

A) 3291, 3356, 3619, 3645, 3638, 3919, 2618, 2616 B) 3799

Philips Medical Systems (Cleveland), Inc.

A) 80338, 7379 B) 80025 C) 11019 D) 80063, 80258 E) 80588, 80662

Brainlab AG Medtronic Navigation, Inc. (Littleton) Siemens AG Baxter Healthcare Corporation

2011-01-10 2011-01-10 2011-01-10 2011-01-10

2010-11-30 59387 2010-10-18 58889 2010-11-25 59312 2010-12-02 59460

Type II Type II Type III Type II

18117 9732719 77 40 769 2B8071

A) 7008605 B) 5904441 C) 5904466 D) 59 17 054

American Medical Systems

534g, 543h, 537g, 310c, 1 unknown

GE Medical Systems LLC

Centricity Laboratory - Core Lab Stealthstation S7 - Cart

GE Healthcare IT Medtronic Navigation, Inc.

2010-08-18 58397 2010-11-08 58590

GE Healthcare Japan Corpoation

A) S9116LA B) A90962AC C) S9116LE/ME D) S9116LR E) B7868JA/JD

Heartstart FR2+ Semiautomatic Defibrillator - Main Unit

Philips Medical Systems

Sterile Intermediary Tube Sets

>10 Numbers, Contact Manufacturer

Medtronic Inc. Instrumentation Laboratory Co.

2010-10-01 57324 2010-11-11 58956

8731SC A) 0000880311 B) 0001000311 C) 0000990011 85-5037 SR0110C 04738578191

Benlan Inc. Oxoid Limited Roche Diagnostics GMBH

2011-01-10 2011-01-10 2011-01-10

2010-11-17 59025 2010-11-17 59075 2010-11-29 59326

Type III Type II Type III

Stryker Navigation System - Intellect Cranial Software

Stryker Leibinger GMBH & Co. KG

6000-650-000, 6000-650-100, 6000-651-000, 6000-651-200, 6000-652-000

3001, 3002, 3003, 3004, 3010, 3031

Roche Diagnostics GMBH

Ligasure Blunt Tip Laparoscopic Sealer/Divider

Medtronic Xomed Inc.

A) 8253200 B) 8253410 01-7110, 01-7112

2010-11-29 59398 2010-12-06 59631

Type II Type III

A) N/A B) N/A M70600055

A) Contact Manufacturer B) Contact Manufacturer All Serial Numbers

EZ-OX Oxygen Regulator

Western/Scott Fetzer Co.

All Serial Numbers

Temperature Management System

Cincinnati Sub-Zero Products

S/N 061-3-00001 - 101-3-01389

A) 840.01 B) 810-45 C) 820.01

A) Cobas Integra System - Acetaminophen B) Roche Hitachi - Acetaminophen

Roche Diagnostics GMBH

A) Contact Manufacturer B) Contact Manufacturer

Trinity Biotech USA Beckman Coulter, Inc.