Field Safety Notice Page 1 of 6

Computed Tomography FSN _72800696 Revision: 01 March 2018

URGENT - Field Safety Notice

Medical Device Correction
Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP,
Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance
64, IQon, Brilliance 6, Brilliance 10
Couch Horizontal Motion Controller

Dear Customer,

A problem has been detected in certain Philips CT couches used on Ingenuity Flex, Ingenuity CT,
Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP, Brilliance Big Bore Oncology,
Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance 64, IQon, Brilliance 6, Brilliance
10 systems, that, if it were to re-occur, could pose a risk to patients or users. This Field Safety
Notice is intended to inform you about:
• what the problem is and under what circumstances it can occur
• the actions that should be taken by the customer / user in order to prevent risks for
patients or users
• the actions planned by Philips to correct the problem.

This document contains important information for the continued safe and proper use of your
equipment

Please review the following information with all members of your staff who need to be aware of the
contents of this communication. It is important to understand the implications of this communication.

Please retain a copy with the equipment Instruction for Use.

If you need any further information or support concerning this issue, please contact your local
Philips representative:

0800 80 3000

This notice has been reported to the appropriate Regulatory Agency.

Sincerely,

Holly Wright Lee

Sr. Manager, Quality & Regulatory

Philips Medical Systems (Cleveland), Inc.

595 Miner Road, Highland Heights, Ohio 44143 U.S.A
 Field Safety Notice Page 2 of 6
Computed Tomography FSN _72800696 Revision: 01 March 2018

URGENT - Field Safety Notice

Medical Device Correction
Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP,
Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance
64, IQon, Brilliance 6, Brilliance 10
Couch Horizontal Motion Controller

AFFECTED PRODUCTS Ingenuity Flex - 728317

Ingenuity CT - 728326, 728325
Ingenuity Core - 728321
Ingenuity Core128 - 728323, 728324
Brilliance iCT - 728306
Brilliance iCT SP - 728311
Brilliance Big Bore (Oncology) - 728243
Brilliance Big Bore (Radiology) - 728244
Brilliance 16 Slice (Air) - 728246
Brilliance 16 Slice (Power) - 728240
Brilliance 40 - 728235
Brilliance 64 - 728231
IQon Spectral CT - 728332
Brilliance 6 Slice (Air) - 728256
Brilliance 10 Slice (Air) – 728251
Brilliance CT Private Practice CV config. - 728241

PROBLEM Upon closing the Emergency Stop (E-STOP) the system performs an
DESCRIPTION internal check. As a result of the motion controller in the couch, there is a
delay in the response to the internal check. This delay may cause the
couch carbon top to enter a free float state, which may allow it to move
during patient load or unload activities. This free float motion results in the
ESTOP being opened due to the unexpected couch motion.

This issue occurs frequently after closing E-STOP. The motion controller in
the couch detects a power problem and disables the horizontal motor,
which allows the couch top to free-float*.
*The term free float refers to the couch top being in a state that is not
locked in position by the brake or being moved in a controlled fashion
(manual or automatic motion).

HAZARD INVOLVED The couch horizontal motion controller does not respond as expected,
allowing the couch to free float without notification to the user once E-
STOP is closed during normal use. If the couch is in free float state and the
operator attempts to load a patient, serious injury to a patient and/or
operator may occur due to unintended horizontal couch motion.

Philips Medical Systems (Cleveland), Inc.

595 Miner Road, Highland Heights, Ohio 44143 U.S.A
 Field Safety Notice Page 3 of 6
Computed Tomography FSN _72800696 Revision: 01 March 2018

URGENT - Field Safety Notice

Medical Device Correction
Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP,
Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance
64, IQon, Brilliance 6, Brilliance 10
Couch Horizontal Motion Controller

HOW TO IDENTIFY There are two sets of serial number ranges that may be impacted. Serial
AFFECTED PRODUCTS numbers can be either five digit or six digit numbers. The patient support
(couch) serial number can be found on a label located on the front closest
to the gantry of the patient support (couch) cover. Refer to Figure 1 and
Figure 2 for examples of serial numbers. Refer to Table 1 and Table 2 for
list of affected patient support (couch).

Figure1 (Example: six digit serial number):

Philips Medical Systems (Cleveland), Inc.

595 Miner Road, Highland Heights, Ohio 44143 U.S.A
 Field Safety Notice Page 4 of 6
Computed Tomography FSN _72800696 Revision: 01 March 2018

URGENT - Field Safety Notice

Medical Device Correction
Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP,
Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance
64, IQon, Brilliance 6, Brilliance 10
Couch Horizontal Motion Controller

Figure2 (Example: five digit serial number):

The following CT couch six digit serial number ranges are affected:

Table 1:

Ranges of affected six

digit Serial Numbers
901001 - 901992
911001 - 911221

921001 - 921369

931001 - 931044

941001 - 941137

951001 - 951130

957001 - 957050

Philips Medical Systems (Cleveland), Inc.

595 Miner Road, Highland Heights, Ohio 44143 U.S.A
 Field Safety Notice Page 5 of 6
Computed Tomography FSN _72800696 Revision: 01 March 2018

URGENT - Field Safety Notice

Medical Device Correction
Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP,
Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance
64, IQon, Brilliance 6, Brilliance 10
Couch Horizontal Motion Controller

The following CT couch five digit serial number ranges are affected:

Table 2:

Ranges of affected five digit Serial Numbers

30191 thru 30194 30196 30197
30199 30200 30202
30204 30205 30209
30210 30214 thru 30216 30218 thru 30226
30228 thru 30231 30234 30235
30237 30238 30240 thru 30257
30263 30271 30277
40083 thru 40086 40088 thru 40101 40103
40104 40106 40108 thru 40112
40117 40118 40124
40127 thru 40143 40146 thru 40152 40155
40157 40159 thru 40165 40167
40169 thru 40186 40188 40189
40191 40192 40195
40212 thru 40215 40217
50535 thru 50543 50545 50546
50548 thru 50556 50558 thru 50568 50570 thru 50574
50577 50579 50582
50585 50597 thru 50599 50601 thru 50622
50625 50626 50628
50632 thru 50635 50637 thru 50640 50642 thru 50646
50648 thru 50651 50653 thru 50655 50657
50658 50661 thru 50663 50665 thru 50684
50689 50691 50693
50697 50705 50707
60148 thru 60155 60157 thru 60163 60165
60169 60171 thru 60187
83200 thru 83208 83210 thru 83214 83216 thru 83220
83223 thru 83238 83241 thru 83244 83247
83249 thru 83251 83253 83281
83282 83284 thru 83310 83312 thru 83314
83317 83319 83321 thru 83339

Philips Medical Systems (Cleveland), Inc.

595 Miner Road, Highland Heights, Ohio 44143 U.S.A
 Field Safety Notice Page 6 of 6
Computed Tomography FSN _72800696 Revision: 01 March 2018

URGENT - Field Safety Notice

Medical Device Correction
Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP,
Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance
64, IQon, Brilliance 6, Brilliance 10
Couch Horizontal Motion Controller

83342 83345 thru 83351 83353 thru 83356

83358 83360 thru 83362 83365 thru 83381
83384 83386 thru 83359 83461 thru 83473
83476 thru 83487 83489 thru 83494 83496 thru 83503
83505 thru 83513 83515 thru 83523 83525 thru 83549
83551 83552 83561 thru 83564
83567 thru 83570 83574 thru 83577 83579 thru 83581
83584 83586 83587
83589 83593 83594
83596 thru 83599
91092 thru 91096 91098 91099
91101 91105 thru 91110 91112
91114 thru 91117 91133 91135 thru 91139
91141 thru 91146 91148 91151 thru 91159
91161 thru 91164 91166 thru 91176 91178 thru 91181
91183 thru 91188 91190 91192 thru 91205
91207 thru 91219 91237 91253

ACTION TO BE TAKEN Once the E-stop has been closed the operator/technologist must initiate a
BY CUSTOMER / USER brief horizontal motion (in or out) using any of the operator control panels,
CT-Box or tape/foot switches. This action will ensure the couch carbon top
(upper pallet) is in a controlled state.

ACTIONS PLANNED BY Philips Healthcare is notifying the affected users of the issue via this Field
PHILIPS Safety Notice. Field Change Order (FCO) 72800696 will be deployed to
correct the issue. A Philips Field Service Engineer will contact you to
schedule the updates at your site.

FURTHER If you need any further information or support concerning this issue, please
INFORMATION AND contact your local Philips representative:
SUPPORT
0800 80 3000

Philips Medical Systems (Cleveland), Inc.

595 Miner Road, Highland Heights, Ohio 44143 U.S.A