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URGENT MEDICAL DEVICE CORRECTION

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Subject:

Reference / FSCA Identifier:


Date of Notification:
Type of Action:

Improper scaling of reference CT images in the 3D


Match environment.
OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline
Review 1.0 - 2.0
CP-05007
2012-11-05
Notification and Correction

Details on Affected Devices:

Refer to Appendix C/D.

Commercial Name of Affected Product:

Description of Problem:
This letter is to advise you of an anomaly that 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 behavior
than the other products identified in this notification. This notice provides a description of the
issue, the actions you can take to avoid the issue, and steps Varian is taking to address the
issue.

Background:
In the 3D Match environment the CT slices from a reference CT are converted into a CT volume
for display. To minimize use of computer memory, the CT volume is always represented
internally using 250 slices, even if the original CT dataset contains more slices. When CT
datasets with greater than 250 slices are used, internally the original CT slices are re-sampled
so that only 250 slices exist in memory.

Details:
The problem lies in the logic used to determine when the re-sampling of the CT dataset should
occur. Due to flaws in the logic, on occasion the re-sampling will not be performed, even though
the original CT dataset contains more than 250 slices. The result will be a CT volume that is
displayed as being larger in the slice direction than it should be (see Figure 1). There is no
geometric error at the inferior end of the CT volume and maximum geometric error at the
superior end of the CT volume.

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The anatomy within any slice is displayed properly. And any structures drawn on top of the CT
volume are also scaled properly. Therefore, it is possible to recognize this problem because
there will be a mis-alignment between the CT volume and the structures in sagittal and coronal
views, although it may be difficult to detect the issue in the axial view.
The problem only occurs if (i) the slice spacing in the CT dataset is uniform throughout the
entire CT dataset; (ii) the CT dataset contains a number of CT slices in a critical range (see
Table 1 and Appendix A); (iii) the CT dataset is used in conjunction with CBCT image
acquisition; and, (iv) the CT slices are ordered so that the CT slice with the smallest CT couch
position is the slice that reaches the scaling logic first. Because of these multiple factors, the
probability of encountering the problem is likely small, but is very difficult to predict.

THE PROBLEM:
The CT volume
(gray-scale image) is
stretched.
The structures and
CT volume are not
aligned.

Figure 1: An improperly scaled reference CT showing a stretched CT volume. The structures are
scaled properly and are displayed accurately.

Affected CT Datasets:
Only CT datasets with the number of slices in a critical range are subject to the problem. If the
number of CT slices in the dataset exceeds a certain value, which depends upon the slice
thickness, then the CT volume is re-sampled properly, and no scaling problem appears. And no
problem occurs for CT datasets containing 250 or fewer CT slices. Therefore, the problem

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exists only for CT datasets that contain a narrow range of CT slices. Table 1 shows that range
for a number of slice thicknesses. Appendix A gives a more complete listing.

Slice
Thickness

Number of
Slices:
Lower Limit

Number of
Slices:
Upper Limit

Number of
Affected
CT Slices

Maximum
Error
[mm]

0.5
1.0
1.25
1.5
2.0
2.5
3.0
5.0

251
251
251
251
251
251
251
251

299
274
269
266
262
259
258
254

49
24
19
16
12
9
8
4

24.5
24.0
23.75
24.0
24.0
22.5
24.0
20.0

Table 1: The size of CT datasets that are affected by the problem and the magnitude of the
maximum error. CT datasets containing number of slices below the Lower Limit, or above the
Upper Limit, will not be affected by the problem.

Magnitude of the Geometric Error:


The geometry of the CT volume is correct at the inferior end of the CT volume and the
maximum error occurs at the superior end of the CT volume (see Figure 1). The error at any
intermediate location scales linearly with position relative to the ends. Therefore, the treatment
isocenter location - typically in the middle of the CT volume - would have an error 50% of the
maximum error.
The magnitude of the maximum scaling error for any CT dataset depends upon how many
slices above 250 that the CT dataset contains. The maximum scaling error (i.e., the error at the
superior end of the CT scan) is given by "the number of slices in the CT dataset greater than
250" times "the slice thickness". If the maximum scaling error becomes equal to, or larger than,
25.0 mm, then the CT dataset is outside of the critical range where the error will occur. The
maximum scaling error for some slices is listed in Table 1 and a more complete list is in
Appendix A.
Error (at superior end) = (Number of slices in CT dataset 250) * slice thickness. (Eq. 1)
[for Error < 25 mm]
Error (at superior end) = 0 if number of slices <= 250
Error (at superior end) = 0 if Error >= 25 mm
The magnitude of the maximum scaling error as a function of slice number, and for selected
slice thicknesses, is shown in Figure 2.

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Figure 2: Error at the superior end of the CT dataset as a function of number of CT slices in the CT
dataset for (left-to-right) 3.0 mm, 2.5 mm, 2.0 mm and 1.0 mm slice thicknesss.

Ordering of the CT Slices:


The order in which the CT slices are sent to the 3D Match environment is important. The scaling
problem occurs only if the first slice from the CT dataset reaching the 3D Match environment is
the CT slice with the smallest CT couch position. With any other slice order, no scaling problem
will occur, even though the CT dataset contains the number of CT slices in the critical range.
The slice order depends upon the product and software version, as well as clinical practice.

OBI 1.5
In OBI 1.5, the order that the CT slices is received by the 3D Match environment is the
same as the order in which the CT slices are saved in the database. The database is not
designed to store CT slices in a defined order, so the exact order of saving and
retrieving CT slices cannot be predicted. However, empirical examination of several
databases shows that the probability that the CT slice with the smallest couch position
being loaded first ranges between 1/5 1/2. This number appears to depend upon
clinical practice, and it is speculated that the CT slice order is related to the direction the
CT table is moving when the CT dataset is acquired. As a result, 1/5 1/2 of the CT
datasets that contain the critical number of CT slices may exhibit the scaling problem.

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The scaling problem will also appear in the OBI 1.5 3D Match environment every time
the CT dataset is loaded and used.

OBI 1.3, OBI 1.4, Offline Review 1.0, 1.1, 1.2, 1.3, 2.0 and TrueBeam 1.0
In these products, the loading of the CT slices goes through an intermediate step where
the CT slices are placed in a cache before being sent to the 3D Match environment. The
order that CT slices are accessed from the cache is random. Therefore, the probability
that the CT slice with the smallest couch position being loaded first is 1/(number of
slices), which is ~ 1/250. Therefore, there is a much lower probability that the scaling
problem will be encountered with these product versions. Furthermore, because the
ordering of the CT slices is random, the problem may appear one day and not appear
subsequently.

Recommended User Actions


Review your clinical matching process. If you do not use the CT volume (gray-scale image) for
matching but overlay the structures on top of the acquired CBCT, then this scaling problem will
not affect you. This is because the structures have the proper dimensions.
Stop using CT datasets in the critical CT slice range. Use the information in Table 1 or Appendix
A to determine the critical CT slice range for the CT slice thicknesses that your clinic uses. If
you have any patients on treatment with a reference CT in the critical CT slice range, create a
new CT volume in your treatment planning system using fewer CT slices and copy the existing
plan to the new volume. If you use Eclipse as your treatment planning system, and are not
familiar with the process of reducing the number of slices in a CT volume, contact the Varian
Help Desk. For guidance, one method to reduce the number of CT slices in a CT volume is
described in Appendix B.
It is difficult to check if this problem has occurred with previous patients. While the probability is
quite low with OBI 1.3, OBI 1.4, TrueBeam 1.0 and Offline Review 1.0 2.0, there is no way of
systematically reviewing all matches to see if previous matches were in error.
If one is using OBI 1.5 then checks can be made using Offline Review, because the probability
of a scaling problem occurring is different between the two products. Identify patients with CT
datasets where the number of CT slices is in the critical range. Load these patients into Offline
Review and first verify that there is no display problem in Offline Review by displaying a coronal
slice and comparing the body outline with the CT volume (e.g., see Figure 1). Examine the 3D
match. If the match appears correct in Offline Review, then the scaling problem is not likely to
have occurred in OBI 1.5. The error to look for is the CBCT dataset being positioned too far
superiorly. Any checks in Offline Review are best done using sagittal and coronal views.

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Varian Actions:

Varian is notifying all possibly affected customers with this document.

Varian is developing a correction for this issue for OBI 1.5. You will be contacted by a
Varian Service representative when this correction (OBI 1.5.17 or higher) is available to
schedule its installation on your system.
Varian is developing a correction for this issue for OBI 1.4. You will be contacted by a
Varian Service representative when this correction (OBI 1.4.14 or higher) is available to
schedule its installation on your system.
OBI 1.3 software has reached its end-of-support [A letter entitled "End of support
announcement for On-Board Imager kV imaging system, version 1.3" dated 25 March
2011 was sent to all OBI 1.3 customers]; therefore, Varian does not plan to develop a
correction for OBI 1.3. Contact your Varian service representative to arrange and
upgrade of your OBI 1.3 system to a more recent version of OBI. The upgrade from OBI
1.3 to OBI 1.4 is available at no charge to all customers.
All TrueBeam 1.0 installations will be updated with TrueBeam 1.5 software. TrueBeam
1.5 does not suffer from the issue described in this communication.

Please advise the appropriate personnel working in your radiotherapy department of the
content of this letter. For future reference, this document will be posted to the Varian
customer support website: http://www.MyVarian.com.
Special Instructions for customers outside the USA and Canada: In order to satisfy
regulatory requirements, we request that you complete the attached Proof of Notification or
Receipt Verification Card once you have read this document and return it to Varian Medical
Systems.
We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If
you require further clarification, please feel free to contact your local Varian Customer Support
District or Regional Manager.
The undersigned confirms that this notice has been provided to the appropriate Regulatory
Agency.

Mika Miettinen
Director, Global Quality Assurance and Product Reliability

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Varian Oncology Help Desk Contact Information:

Phone:

USA and Canada 1-888-VARIAN5 (888- 827-4265)


Europe - +41 41 749 8844

Email:

North America: support-americas@varian.com


Australia/New Zealand: support-anz@varian.com
Europe: support-emea@varian.com
South East Asia: support-sea@varian.com
China / Asia: support-china@varian.com
Japan: support-japan@varian.com
Latin America: soporte.al@varian.com

Internet:

Oncology Systems customer site - www.myvarian.com


Varian Medical Systems public site - www.varian.com

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Appendix A: The size of CT datasets that are affected by the problem


CT datasets containing number of slices below the Lower Limit, or above the Upper Limit, will
not be affected by the problem.

Slice
Thickness

Number of
Slices:
Lower Limit

Number of
Slices:
Upper Limit

0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
1.1
1.2
1.25
1.3
1.4
1.5
1.6
1.7
1.8
1.9
2.0
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
3.0
3.1
3.2
3.3
3.4

251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251

333
312
299
291
285
281
277
274
272
270
269
269
267
266
265
264
263
263
262
261
261
260
260
259
259
259
258
258
258
258
257
257
257

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Number of Maximum
Affected
Error
CT Slices
[mm]
83
62
49
41
35
31
27
24
22
20
19
19
17
16
15
14
13
13
12
11
11
10
10
9
9
9
8
8
8
8
7
7
7

24.9
24.8
24.5
24.6
24.5
24.8
24.3
24.0
24.2
24.0
23.75
24.7
23.8
24.0
24.0
23.8
23.4
24.7
24.0
23.1
24.2
23.0
24.0
22.5
23.4
24.3
22.4
23.2
24.0
24.8
22.4
23.1
23.8

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3.5
3.6
3.7
3.8
3.9
4.0
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
5.0
6.0
7.0
8.0
9.0
10.0

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251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251
251

257
256
256
256
256
256
256
255
255
255
255
255
255
255
255
254
254
253
253
252
252

7
6
6
6
6
6
6
5
5
5
5
5
5
5
5
4
4
3
3
2
2

24.5
21.6
22.2
22.8
23.4
24.0
24.6
21.0
21.5
22.0
22.5
23.0
23.5
24.0
24.5
20.0
24.0
21.0
24.0
18.0
20.0

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Appendix B: Creating a new 3D Image (CT volume)


This Appendix describes how to create a new 3D Image (CT volume) from an existing 3D Image
when Eclipse is used for treatment planning. This Appendix only needs to be reviewed if you
currently have patients on treatment whose reference CT datasets fall into the critical range.
Please contact the Varian Help Desk if you need assistance with these instructions.
The following example shows how to generate a new 3D Image in Eclipse with a reduced number of CT
slices. The scaling anomaly can be avoided by reducing the number of CT slices to 250 slices or less. In
the example, there are 255 transverse images with a slice separation of 2 mm. The tumor volume lies in
the superior aspect of the lung. It is necessary to provide an accurate DVH for the lung structure, but
there are several transverse slices at the inferior aspect of the data set which lie far outside the anatomic
region of interest and would not affect the DVH or dose calculation to the critical and normal tissues.
Therefore, these inferior CT slices may be excluded during the creation of a new CT volume.
1.) Go to Selection.
2.) Highlight the CT Series folder in the scope window and, while holding down the left mouse button,
drag this object to the far right:

In "Selection", highlight the


planning CT Series folder in
the scope window (at the
upper left) and drag it to the
far right, so that all of the
transverse images load to the
gallery.

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As a result, all of the transverse images in the CT data stack will be loaded in the gallery:

As a result, all of the transverse images in


the CT data set are loaded to the gallery. In
this case, a total of 255 CT slices.

3.) Only the transverse images open in the gallery will be utilized for the creation of the new 3D Image. By
"closing" some slices, the number of CT slices used to form the 3D Image can be reduced.
Note: Only remove CT slices that will not affect planning properties such as DVHs or dose calculations.
Furthermore, even if the slice thickness was varied during acquisition of the CT images, the 3D image
created will have a uniform slice thickness.

While holding down the left mouse button, drag the mouse over the slices in the gallery which the user
has determined can be excluded from the 3D image till they appear highlighted, then right mouse click
(RMC) and select Close:

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While holding down the left mouse


button, highlight the individual
transverse images at the inferior
aspect of the data stack. While these
slices are still highlighted, RMC and
select "Close".

Note: Do NOT choose to delete these images.


4.) The slice count now in the gallery will be reduced. RMC on any remaining individual transverse
thumbnail and create a new 3D Image (CT volume):

Now only 247 images


appear in the gallery.
RMC and create
"New 3D Image".

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5.) In the ensuing 3D image creation dialog box, the user will confirm the resulting number of slices, as
well as the slice separation. A unique ID must be provided for this new 3D Image:

Specify a unique ID for this


new 3D image:

Verify the
resulting image count
and plane separation
(i.e., slice thickness).

6.) In Eclipse versions 8.1 through 10, the new 3D Image will automatically be registered to the original
3D (as seen in the focus window under the yellow Registered Images folder):

The new 3D
image is
automatically
registered by
the system to
the original
3D in Eclipse
versions 8.1
through 10.

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7.) In such instances, the user can skip Registration and proceed directly to Contouring. Drop the
original 3D Image to view, so that all of the original structures are visualized. RMC on the structure set
icon (or on the original 3D Image, depending on the Eclipse software version) and select to copy the
structures:

The original 3D image will be at the top of the


focus window hierarchy. In Eclipse 8.1 through
8.5, RMC on this 3D image>Copy>Structures.
However, in Eclipse versions 8.6 through 10 (as
shown), RMC on the structure set icon and select
Copy all Structures.

8.) Drop the new 3D Image back to view (so it is now at the top of the focus window hierarchy), RMC and
Paste Structure(s):

The original 3D image is now


back at the top of the focus
window hierarchy.

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In later versions, the user may be asked to provide a name for the newly pasted structure set.
Review the resulting structures to ensure correctness.
9.) Proceed to External Beam Planning (or the Field Setup Workspace, depending on the version of
Eclipse) and drop the original plan to view.
10.) RMC on the existing plan>Copy Plan.
11.) RMC again on the same plan>Paste Plan or Paste Plan with Reference Images (depending on
Eclipse version). Provide a unique ID for this new plan.
12.) RMC on the newly pasted plan>Assign Patient Image (in versions 8.1 through 8.5) or >Assign
Structure Set (in Eclipse versions 8.6 through 10). Depending on the Eclipse version, choose either the
3D image or the structure set created in step 5 (or 8) from the Object Explorer Window. Once this
occurs, the MU will be stripped from the plan. This is normal system behavior.
13.) If the institution uses the Set User Origin tool, this will NOT be preserved after associating the new
plan to the new 3D image/structure set. Therefore, this step must be performed again. Check that the
proper coordinates are utilized in the plan (as displayed in the Info Window at the bottom of the screen,
as well as by examining the isocenter location on an orthogonal pair of DRRs/fields in the BEV).
14.) In Eclipse versions 8.1 through 8.5, go to Planning>Dose Calculation>Calculate Volume with
Fixed MUs. In Eclipse versions 8.6 through 10, go to Planning>Dose Calculation>Calculate Volume
with Preset Values.
15.) Verify that the MUs, as well as the dose/fraction, prescribed percentage, and plan normalization
value are the same as per the original plan. If correct, click Apply:

Verify all parameters


(including MU, the
prescription,
prescribed percentage,
and plan normalization
value).

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The fields should be recalculated. When the calculation is complete, the above preset values dialog box
will still appear, so click OK to close it.
Compare in Plan Evaluation the resulting dose distribution and dvh of this plan as compared to the
original plan. There may be slight MU/dose rounding. If there is a significant difference, then the user is
cautioned to review the steps taken and/or to call the Eclipse Help Desk for further support, troubleshooting, and evaluation. If no deviation is noted, then go back to External Beam Planning or the Field
Setup Workspace and change the number of remaining fractions to be delivered in the Info Window for
this newly pasted/recalculated plan. Then issue planning/treatment approval as usual. Also remember to
Complete Early the original plan, so it will no longer be valid for treatment.
Note: During the calculation, the leaf motion calculator (LMC) should NOT re-run. If the user sees the
leaf motion calculator dialog box (normally seen just after the optimization window closes), then abort the
process. Do NOT let the LMC re-run or a leaf sequence can be generated which can be different than
that which was originally QAd. At this point, call the Eclipse Help Desk (as the additional steps
necessary are outside the scope of this document).

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APPENDIX C
LIST OF SERIAL NUMBERS
H080002
H080003
H080004
H080005
H080006
H080008
H080009
H080010
H080011
H080012
H080013
H080014
H080016
H080017
H080018
H080019
H080020
H080021
H080022
H080024
H080026
H080027
H080028
H080029
H080030
H080031
H080032
H080033
H080034
H080035
H080036
H080037
H080038
H080039
H080040
H080041
H080042
H080043
H080044
H080045
H080046
H080047
H080048
H080049
H080050
H080051
H080052
H080053
H080054
H080055
H080056
H080057
H080059
H080060
H080061
H080062
H080063
H080064

H080065
H080066
H080068
H080069
H080070
H080071
H080072
H080073
H080074
H080075
H080076
H080077
H080078
H080079
H080080
H080081
H080082
H080083
H080084
H080085
H080086
H080087
H080088
H080089
H080090
H080091
H080092
H080093
H080094
H080095
H080096
H080097
H080099
H080100
H080101
H080102
H080103
H080104
H080105
H080107
H080108
H080109
H080110
H080111
H080112
H080113
H080114
H080115
H080116
H080117
H080118
H080119
H080120
H080121
H080122
H080123
H080124
H080125

H080126
H080127
H080128
H080129
H080130
H080131
H080132
H080133
H080134
H080136
H080137
H080138
H080139
H080140
H080141
H080142
H080143
H080144
H080145
H080147
H080148
H080149
H080150
H080151
H080152
H080153
H080154
H080155
H080156
H080157
H080158
H080159
H080160
H080161
H080162
H080163
H080164
H080165
H080166
H080167
H080168
H080169
H080170
H080171
H080172
H080173
H080174
H080175
H080176
H080177
H080178
H080179
H080180
H080181
H080182
H080183
H080184
H080185

H080186
H080187
H080188
H080189
H080190
H080191
H080192
H080193
H080194
H080195
H080196
H080197
H080198
H080199
H080200
H080202
H080203
H080204
H080205
H080206
H080207
H080208
H080209
H080210
H080211
H080212
H080213
H080214
H080215
H080216
H080217
H080218
H080219
H080220
H080221
H080222
H080224
H080225
H080226
H080227
H080228
H080229
H080230
H080231
H080232
H080234
H080235
H080236
H080237
H080238
H080239
H080240
H080243
H080244
H080245
H080246
H080247
H080248

Varian PN CP-05007 Rev C

H080250
H080251
H080252
H080254
H080255
H080256
H080257
H080258
H080259
H080260
H080261
H080262
H080263
H080264
H080265
H080266
H080267
H080268
H080269
H080270
H080271
H080272
H080273
H080274
H080275
H080276
H080278
H080279
H080280
H080281
H080282
H080283
H080286
H080287
H080288
H080289
H080290
H080291
H080292
H080294
H080295
H080296
H080297
H080298
H080299
H080300
H080301
H080302
H080303
H080304
H080305
H080306
H080307
H080308
H080309
H080310
H080311
H080312

H080313
H080314
H080315
H080316
H080317
H080318
H080319
H080320
H080321
H080322
H080324
H080325
H080326
H080327
H080328
H080329
H080330
H080331
H080332
H080333
H080334
H080335
H080336
H080337
H080338
H080339
H080340
H080341
H080342
H080344
H080345
H080346
H080347
H080348
H080349
H080350
H080351
H080352
H080353
H080354
H080355
H080356
H080357
H080358
H080359
H080360
H080361
H080362
H080363
H080364
H080365
H080366
H080368
H080369
H080370
H080371
H080373
H080374

H080375
H080376
H080377
H080378
H080379
H080380
H080381
H080382
H080383
H080384
H080385
H080386
H080387
H080389
H080391
H080392
H080393
H080394
H080395
H080396
H080397
H080398
H080399
H080400
H080401
H080402
H080403
H080404
H080405
H080406
H080407
H080408
H080409
H080410
H080411
H080412
H080413
H080414
H080415
H080416
H080417
H080418
H080419
H080420
H080421
H080423
H080424
H080425
H080426
H080427
H080428
H080429
H080430
H080431
H080432
H080433
H080435
H080436

H080437
H080438
H080439
H080440
H080441
H080442
H080443
H080444
H080445
H080446
H080447
H080448
H080449
H080450
H080451
H080452
H080453
H080454
H080455
H080456
H080457
H080458
H080459
H080460
H080461
H080462
H080463
H080464
H080465
H080466
H080467
H080468
H080469
H080470
H080471
H080472
H080473
H080474
H080476
H080477
H080478
H080479
H080480
H080481
H080482
H080484
H080485
H080486
H080487
H080488
H080489
H080490
H080491
H080492
H080493
H080494
H080495
H080496

H080497
H080498
H080499
H080500
H080501
H080502
H080503
H080504
H080506
H080507
H080508
H080509
H080510
H080511
H080512
H080513
H080514
H080515
H080516
H080517
H080518
H080519
H080520
H080521
H080522
H080523
H080524
H080525
H080526
H080527
H080528
H080529
H080530
H080531
H080532
H080534
H080535
H080536
H080537
H080538
H080539
H080540
H080541
H080542
H080543
H080544
H080545
H080546
H080547
H080548
H080549
H080550
H080551
H080552
H080553
H080554
H080555
H080557

H080558
H080601
H080602
H080604
H080605
H080606
H080607
H080608
H080609
H080610
H080611
H080612
H080613
H080614
H080615
H080616
H080617
H080618
H080619
H080620
H080621
H080622
H080623
H080624
H080625
H080626
H080627
H080628
H080629
H080630
H080631
H080632
H080633
H080634
H080635
H080636
H080637
H080638
H080641
H080642
H080643
H080644
H080645
H080646
H080647
H080650
H080651
H080652
H080653
H080654
H080655
H080656
H080657
H080659
H080660
H080661
H080662
H080663

H080664
H080665
H080666
H080667
H080668
H080669
H080670
H080672
H080673
H080674
H080675
H080676
H080677
H080678
H080679
H080680
H080683
H080684
H080685
H080686
H080687
H080688
H080689
H080690
H080691
H080692
H080693
H080695
H080696
H080697
H080698
H080699
H080700
H080701
H080702
H080703
H080706
H080707
H080708
H080709
H080710
H080711
H080712
H080713
H080714
H080716
H080717
H080718
H080726
H080727
H080728
H080729
H080730
H080733
H080734
H080736
H080738
H080739

H080740
H080741
H080742
H080745
H080746
H080747
H080748
H080749
H080753
H080754
H080755
H080759
H080760
H080761
H080762
H080763
H080764
H080766
H080768
H080772
H080773
H080774
H080775
H080778
H080783
H080786
H080788
H080791
H080798
H080800
H080801
H080805
H080812
H080836
H080840
H080852
H080857
H080859
H080860
H080861
H080864
H080866
H080868
H080869
H080870
H080873
H080881
H081001
H082000
H082001
H082002
H082003
H082004
H082005
H082006
H082007
H082008
H082009

page 17 of 20

H082010
H082011
H082012
H082013
H082014
H082015
H082016
H082017
H082018
H082020
H082021
H082022
H082023
H082024
H082025
H082026
H082031
H082032
H082033
H082034
H082035
H082036
H082037
H082038
H082039
H082040
H082041
H082042
H082043
H082044
H082045
H082046
H082047
H082048
H082049
H082050
H082051
H082052
H082053
H082054
H082055
H082056
H082057
H082058
H082059
H082060
H082061
H082062
H082063
H082064
H082065
H082066
H082067
H082068
H082069
H082070
H082071
H082072

URGENT MEDICAL DEVICE CORRECTION


URGENT FIELD SAFETY NOTICE

H082073
H082074
H082075
H082076
H082077
H082078
H082079
H082080
H082081
H082082
H082083
H082084
H082085
H082086
H082087
H082088
H082089
H082090
H082091
H082092
H082093
H082094
H082095
H082096
H082097
H082098
H082099
H082100
H082101
H082102
H082103
H082104
H082105
H082106
H082107
H082108
H082109
H082110
H082112
H082113
H082114
H082115
H082116
H082117
H082118
H082119
H082120
H082121
H082122
H082123
H082124
H082125
H082126
H082127
H082128
H082129
H082130
H082131
H082133
H082134
H082135
H082136

H082137
H082138
H082139
H082140
H082141
H082142
H082143
H082144
H082145
H082146
H082147
H082148
H082149
H082150
H082151
H082152
H082153
H082154
H082156
H082157
H082158
H082159
H082160
H082161
H082162
H082163
H082164
H082165
H082166
H082167
H082168
H082169
H082170
H082171
H082172
H082173
H082174
H082175
H082176
H082177
H082179
H082180
H082181
H082182
H082183
H082184
H082185
H082186
H082187
H082188
H082189
H082190
H082191
H082192
H082193
H082194
H082195
H082196
H082197
H082198
H082199
H082200

H082201
H082202
H082203
H082204
H082205
H082206
H082207
H082208
H082209
H082210
H082211
H082212
H082213
H082214
H082215
H082216
H082217
H082218
H082219
H082220
H082221
H082222
H082223
H082224
H082225
H082226
H082227
H082228
H082229
H082230
H082231
H082232
H082233
H082234
H082235
H082236
H082237
H082238
H082239
H082241
H082242
H082243
H082244
H082245
H082246
H082247
H082248
H082249
H082251
H082252
H082253
H082254
H082255
H082256
H082257
H082258
H082259
H082260
H082261
H082262
H082263
H082264

H082265
H082266
H082267
H082268
H082269
H082270
H082271
H082272
H082273
H082274
H082275
H082276
H082277
H082278
H082279
H082280
H082282
H082283
H082284
H082285
H082286
H082287
H082288
H082289
H082290
H082291
H082292
H082293
H082294
H082295
H082296
H082297
H082298
H082299
H082300
H082301
H082302
H082303
H082304
H082306
H082307
H082308
H082309
H082310
H082311
H082312
H082313
H082314
H082315
H082316
H082317
H082318
H082319
H082320
H082321
H082322
H082323
H082324
H082325
H082326
H082327
H082328

Varian PN CP-05007 Rev C

H082330
H082331
H082332
H082333
H082334
H082335
H082336
H082337
H082338
H082339
H082340
H082341
H082342
H082343
H082344
H082346
H082347
H082348
H082349
H082350
H082351
H082352
H082353
H082354
H082355
H082356
H082357
H082358
H082359
H082360
H082361
H082362
H082363
H082364
H082365
H082366
H082367
H082368
H082369
H082370
H082371
H082372
H082373
H082374
H082375
H082376
H082377
H082378
H082379
H082380
H082381
H082382
H082383
H082384
H082385
H082386
H082387
H082388
H082389
H082390
H082391
H082392

H082393
H082394
H082395
H082396
H082397
H082398
H082399
H082400
H082401
H082402
H082403
H082404
H082406
H082407
H082408
H082409
H082410
H082411
H082412
H082450
H082451
H082452
H082453
H082475
H082476
H082480
H082482
H082484
H082485
H082486
H082487
H082488
H082489
H082490
H082491
H082492
H082493
H082494
H082495
H082496
H082498
H082499
H082500
H082501
H082502
H082503
H082504
H082505
H082506
H082507
H082508
H082509
H082510
H082511
H082512
H082513
H082514
H082515
H082516
H082517
H082518
H082519

H082520
H082521
H082522
H082523
H082524
H082525
H082526
H082527
H082528
H082529
H082530
H082531
H082532
H082533
H082534
H082535
H082536
H082537
H082538
H082539
H082540
H082541
H082542
H082543
H082544
H082545
H082546
H082547
H082548
H082549
H082550
H082551
H082552
H082553
H082554
H082555
H082556
H082557
H082559
H082560
H082561
H082562
H082563
H082564
H082565
H082566
H082567
H082568
H082569
H082570
H082571
H082572
H082573
H082574
H082575
H082576
H082578
H082579
H082580
H082581
H082582
H082583

H082584
H082585
H082586
H082587
H082588
H082589
H082590
H082591
H082592
H082593
H082594
H082595
H082596
H082597
H082598
H082599
H082600
H082601
H082602
H082603
H082604
H082605
H082606
H082607
H082608
H082609
H082610
H082611
H082613
H082614
H082615
H082616
H082617
H082618
H082619
H082620
H082621
H082622
H082623
H082624
H082625
H082626
H082627
H082628
H082629
H082630
H082631
H082632
H082633
H082634
H082635
H082636
H082637
H082638
H082639
H082640
H082641
H082642
H082643
H082644
H082645
H082646

H082647
H082649
H082650
H082651
H082652
H082653
H082654
H082655
H082656
H082657
H082658
H082659
H082660
H082661
H082662
H082663
H082664
H082666
H082667
H082668
H082669
H082670
H082671
H082672
H082673
H082674
H082675
H082676
H082678
H082679
H082680
H082681
H082682
H082683
H082684
H082685
H082686
H082687
H082688
H082689
H082690
H082691
H082692
H082693
H082694
H082695
H082696
H082697
H082698
H082699
H082700
H082701
H082702
H082703
H082704
H082705
H082706
H082707
H082708
H082709
H082710
H082711

H082712
H082713
H082714
H082715
H082716
H082717
H082718
H082719
H082720
H082721
H082722
H082723
H082724
H082725
H082726
H082727
H082730
H082731
H082732
H082733
H082734
H082735
H082736
H082737
H082738
H082739
H082740
H082741
H082743
H082744
H082745
H082746
H082747
H082748
H082749
H082750
H082751
H082752
H082753
H082754
H082755
H082756
H082757
H082758
H082759
H082760
H082761
H082762
H082763
H082764
H082765
H082766
H082767
H082768
H082769
H082770
H082771
H082772
H082773
H082774
H082776
H082777

H082778
H082779
H082780
H082781
H082782
H082783
H082784
H082785
H082786
H082787
H082788
H082789
H082790
H082791
H082792
H082794
H082795
H082796
H082797
H082798
H082799
H082800
H082801
H082802
H082803
H082804
H082805
H082806
H082807
H082808
H082809
H082810
H082811
H082812
H082813
H082814
H082815
H082816
H082817
H082818
H082819
H082820
H082821
H082822
H082823
H082824
H082825
H082826
H082827
H082828
H082829
H082830
H082831
H082832
H082833
H082834
H082835
H082836
H082838
H082839
H082840
H082841

H082842
H082843
H082844
H082845
H082846
H082847
H082848
H082849
H082850
H082851
H082852
H082853
H082854
H082855
H082856
H082857
H082858
H082859
H082860
H082861
H082862
H082864
H082865
H082866
H082868
H082869
H082870
H082871
H082872
H082873
H082874
H082875
H082876
H082877
H082878
H082879
H082880
H082881
H082882
H082883
H082884
H082885
H082886
H082887
H082888
H082889
H082890
H082891
H082892
H082893
H082894
H082895
H082896
H082897
H082898
H082899
H082900
H082901
H082902
H082903
H082904
H082905

page 18 of 20

H082907
H082910
H082911
H082912
H082913
H082914
H082915
H082916
H082917
H082919
H082920
H082921
H082922
H082923
H082924
H082925
H082926
H082927
H082928
H082929
H082930
H082931
H082932
H082933
H082934
H082935
H082937
H082938
H082939
H082940
H082941
H082942
H082943
H082944
H082945
H082946
H082947
H082948
H082949
H082950
H082951
H082952
H082953
H082954
H082955
H082957
H082958
H082959
H082960
H082961
H082962
H082963
H082964
H082965
H082966
H082967
H082968
H082969
H082970
H082971
H082972
H082973

URGENT MEDICAL DEVICE CORRECTION


URGENT FIELD SAFETY NOTICE

H082974
H082975
H082976
H082977
H082978
H082979
H082980
H082981
H082982
H082983
H082984
H082985
H082986
H082987
H082988
H082990
H082991
H082993
H082994
H082995
H082996
H082997
H082998
H082999
H083000
H083001
H083002
H083003
H083005
H083006
H083007
H083008
H083009
H083010
H083011
H083012
H083013
H083014
H083015
H083016
H083017
H083018
H083019
H083020
H083021
H083022
H083023
H083024
H083025
H083026
H083027
H083029
H083030
H083031
H083033
H083034
H083035
H083036
H083037
H083038
H083039
H083040

H083041
H083042
H083043
H083044
H083045
H083046
H083047
H083048
H083049
H083050
H083051
H083052
H083053
H083054
H083055
H083056
H083057
H083058
H083059
H083060
H083061
H083062
H083063
H083064
H083065
H083066
H083067
H083068
H083069
H083070
H083071
H083072
H083073
H083074
H083075
H083076
H083077
H083078
H083079
H083080
H083082
H083083
H083084
H083085
H083086
H083087
H083088
H083089
H083090
H083091
H083092
H083093
H083094
H083098
H083103
H083104
H083105
H083106
H083107
H083108
H083109
H083110

H083111
H083112
H083113
H083114
H083115
H083116
H083117
H083119
H083120
H083121
H083122
H083123
H083124
H083125
H083126
H083127
H083128
H083129
H083130
H083131
H083132
H083133
H083135
H083136
H083137
H083138
H083139
H083140
H083141
H083142
H083143
H083144
H083145
H083146
H083147
H083148
H083149
H083150
H083152
H083153
H083154
H083155
H083156
H083157
H083158
H083159
H083160
H083161
H083162
H083163
H083164
H083165
H083166
H083167
H083168
H083169
H083170
H083171
H083172
H083173
H083174
H083175

Varian PN CP-05007 Rev C

H083176
H083177
H083178
H083179
H083180
H083181
H083182
H083183
H083184
H083185
H083186
H083187
H083188
H083189
H083190
H083191
H083192
H083193
H083194
H083195
H083196
H083197
H083198
H083199
H083200
H083202
H083204
H083205
H083206
H083207
H083208
H083210
H083211
H083212
H083213
H083214
H083216
H083217
H083218
H083219
H083220
H083221
H083222
H083224
H083225
H083226
H083227
H083228
H083229
H083230
H083231
H083232
H083233
H083234
H083235
H083236
H083237
H083238
H083239
H083241
H083242
H083243

H083244
H083245
H083246
H083247
H083248
H083249
H083250
H083251
H083252
H083253
H083254
H083255
H083256
H083257
H083258
H083259
H083260
H083261
H083262
H083263
H083264
H083265
H083266
H083267
H083268
H083269
H083270
H083271
H083272
H083273
H083274
H083275
H083276
H083277
H083279
H083280
H083281
H083282
H083283
H083284
H083285
H083287
H083288
H083289
H083290
H083291
H083292
H083293
H083294
H083295
H083297
H083298
H083299
H083300
H083301
H083302
H083303
H083304
H083306
H083308
H083309
H083310

H083311
H083312
H083313
H083314
H083315
H083316
H083317
H083318
H083319
H083321
H083322
H083323
H083324
H083325
H083326
H083327
H083328
H083330
H083331
H083332
H083333
H083334
H083335
H083336
H083337
H083338
H083339
H083340
H083341
H083342
H083343
H083344
H083345
H083346
H083347
H083348
H083349
H083350
H083351
H083352
H083353
H083354
H083355
H083356
H083357
H083358
H083359
H083360
H083361
H083363
H083364
H083365
H083366
H083367
H083368
H083369
H083370
H083371
H083372
H083373
H083374
H083375

H083376
H083377
H083378
H083379
H083380
H083381
H083382
H083383
H083384
H083385
H083386
H083387
H083388
H083389
H083390
H083391
H083392
H083393
H083394
H083395
H083396
H083397
H083398
H083399
H083400
H083401
H083402
H083403
H083404
H083405
H083406
H083407
H083408
H083409
H083410
H083412
H083413
H083414
H083415
H083416
H083417
H083418
H083419
H083420
H083421
H083422
H083423
H083424
H083425
H083426
H083427
H083428
H083429
H083430
H083433
H083434
H083436
H083437
H083438
H083439
H083440
H083441

H083442
H083443
H083445
H083446
H083448
H083449
H083450
H083451
H083452
H083453
H083454
H083455
H083456
H083457
H083458
H083459
H083461
H083462
H083463
H083464
H083465
H083466
H083467
H083469
H083470
H083471
H083473
H083475
H083476
H083478
H083480
H083481
H083482
H083484
H083485
H083486
H083487
H083488
H083489
H083490
H083491
H083492
H083494
H083495
H083496
H083497
H083499
H083500
H083502
H083503
H083504
H083505
H083506
H083507
H083508
H083509
H083510
H083511
H083512
H083513
H083514
H083515

H083516
H083517
H083518
H083519
H083521
H083522
H083523
H083524
H083525
H083526
H083527
H083529
H083530
H083532
H083533
H083534
H083536
H083537
H083539
H083540
H083541
H083543
H083544
H083546
H083548
H083549
H083550
H083551
H083552
H083553
H083556
H083557
H083558
H083559
H083560
H083561
H083562
H083563
H083564
H083565
H083566
H083567
H083568
H083569
H083571
H083572
H083573
H083574
H083575
H083576
H083577
H083578
H083579
H083580
H083581
H083582
H083583
H083584
H083585
H083586
H083587
H083588

H083590
H083591
H083592
H083593
H083594
H083595
H083596
H083599
H083600
H083601
H083602
H083604
H083607
H083608
H083609
H083610
H083611
H083612
H083616
H083617
H083618
H083620
H083621
H083622
H083623
H083624
H083625
H083628
H083629
H083631
H083632
H083634
H083635
H083636
H083637
H083638
H083639
H083642
H083643
H083645
H083646
H083647
H083648
H083650
H083651
H083653
H083654
H083655
H083659
H083662
H083663
H083664
H083665
H083667
H083668
H083670
H083671
H083674
H083682
H083687
H083689
H083690

H083691
H083702
H084338
H191001
H191002
H191003
H191005
H191006
H191007
H191008
H191009
H191010
H191011
H191012
H191013
H191014
H191015
H191019
H191020
H191021
H191022
H191023
H191025
H191026
H191027
H191028
H191029
H191030
H191031
H191032
H191033
H191034
H191035
H191036
H191038
H191039
H191040
H191041
H191042
H191043
H191044
H191045
H191046
H191047
H191048
H191049
H191050
H191051
H191052
H191053
H191054
H191055
H191056
H191057
H191058
H191059
H191060
H191061
H191063
H191064
H191066
H191067

H191069
H191070
H191071
H191072
H191073
H191076
H191077
H191078
H191079
H191080
H191082
H191083
H191085
H191086
H191087
H191088
H191089
H191090
H191091
H191092
H191094
H191095
H191098
H191100
H191101
H191102
H191106

page 19 of 20

URGENT MEDICAL DEVICE CORRECTION


URGENT FIELD SAFETY NOTICE

APPENDIX D
LIST OF SERIAL NUMBERS
H080025
H080070
H080098
H080897
H080936
H080939
H080944
H080947
H080960
H080962
H080969
H080970
H080989
H080991
H080997
H081004
H081005
H081006
H081007
H081009
H081017
H081019
H081020
H081023
H081025
H081026
H081027
H081031
H081034
H081035
H081037
H081038
H081042
H081043
H081044
H081045
H081046
H081050
H081051
H081058
H081067
H081080
H081081
H081082
H081088
H081095
H081100
H081105
H081107
H081108
H081109
H081110
H081112
H081118
H081119
H081120
H081122
H081125

Varian PN CP-05007 Rev C

H081131
H081141
H081148
H081149
H081150
H081153
H081164
H081165
H081169
H081183
H082250
H083444
H083474
H083479
H083483
H083531
H083535
H083547
H083614
H083619
H083627
H083633
H083640
H083644
H083661
H083672
H083676
H083678
H083686
H083693
H083695
H083696
H083700
H083703
H083705
H083706
H083707
H083709
H083710
H083712
H083716
H083721
H083722
H083724
H083725
H083726
H083727
H083729
H083732
H083734
H083737
H083738
H083739
H083740
H083741
H083742
H083743
H083748

H083752
H083754
H083755
H083757
H083758
H083761
H083763
H083764
H083765
H083766
H083767
H083768
H083769
H083770
H083771
H083772
H083773
H083774
H083775
H083777
H083778
H083779
H083780
H083781
H083782
H083783
H083786
H083787
H083788
H083789
H083790
H083791
H083792
H083793
H083794
H083796
H083798
H083799
H083800
H083803
H083804
H083805
H083806
H083807
H083808
H083809
H083810
H083811
H083812
H083813
H083814
H083815
H083816
H083817
H083818
H083819
H083821
H083822

H083824
H083825
H083827
H083830
H083831
H083832
H083833
H083835
H083836
H083837
H083839
H083885
H083941
H083943
H083944
H083946
H083947
H083949
H083950
H083951
H083952
H083953
H083954
H083955
H083957
H083958
H083963
H083964
H083967
H083968
H083969
H083970
H083971
H083973
H083974
H083978
H083979
H083980
H083981
H083983
H083985
H083986
H083988
H083990
H083991
H083993
H083994
H083996
H083997
H083998
H083999
H084000
H084002
H084003
H084004
H084007
H084008
H084010

H084012
H084013
H084016
H084017
H084019
H084021
H084022
H084023
H084024
H084025
H084026
H084028
H084030
H084031
H084032
H084033
H084037
H084039
H084040
H084041
H084042
H084043
H084047
H084051
H084054
H084055
H084057
H084062
H084063
H084064
H084065
H084070
H084077
H084078
H084079
H084080
H084088
H084095
H084096
H084097
H084105
H084111
H084115
H084116
H084119
H084121
H084122
H084128
H084146
H084148
H088675
H089575

page 20 of 20

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