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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips CT Systems Recalled for Patient Table Unexpected Descent Risk

Agency Publication Date: September 19, 2025
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Summary

Philips North America Llc has recalled approximately 910 CT systems, including various models in the Brilliance, Ingenuity, Big Bore, iCT, and IQon series. The recall was initiated because the patient support table (couch) may descend unexpectedly to its lowest position due to a component misalignment (the ball screw) following a replacement procedure. If the table drops during a scan, it could interrupt the exam or potentially cause physical injury to the patient or medical staff. Philips has notified affected customers via letter to arrange for necessary inspections and corrections.

Risk

A misaligned ball screw component can cause the patient table to lose its mechanical hold and drop suddenly to its lowermost position. This unexpected movement poses a risk of traumatic injury to patients currently being scanned or staff working near the equipment.

What You Should Do

  1. This recall involves multiple Philips CT systems including Brilliance CT 40/64 Channel, Brilliance 16 Power/Slice, Big Bore RT, Ingenuity Flex/Core, iCT, IQon Spectral CT, and CT 6000 models.
  2. Check the model number and serial number on your device label to determine if your system is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Philips North America Llc or your local distributor to confirm if your system has had a ball screw replacement and to schedule a technician visit for inspection or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or wish to report a malfunction or injury related to this device.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips CT systems (Brilliance/Ingenuity Flex)
Variants: 40 Channel, 64 Channel, Flex
Model / REF:
728235
728231
728317
Serial Numbers (181):
9223
9115
9225
29144
95647
9194
95341
95234
10051
95488
10098
95695
10309
95217
95698
10443
10544
10531
10712
10662
95834
9990
9784
95632
9058
9089
9522
9580
9688
9877
9806
9808
9671
9694
9703
9830
29068
9821
9869
9837
90144
95203
95225
95303
95328
95362
95402
95395
9852
95492

Recall Number Z-2595-2025

Product: Philips CT systems (Brilliance 16/6 Slice)
Variants: 16 Power, 16 Slice, 6 Slice
Model / REF:
728240
728246
728256
Serial Numbers (73):
6022
5029
5698
5834
6272
6313
5307
5305
50129
5286
50017
5388
5424
5422
5515
5497
5584
5668
5624
5771
5814
5872
5907
5900
5928
5869
5939
5944
5993
6137
5411
6160
6153
5504
6182
6199
6209
6219
6271
6302
6330
6357
6358
6369
6405
6343
6410
6558
6490
6635

Recall Number Z-2596-2025

Product: Philips CT systems (Big Bore)
Variants: RT, Oncology, Standard Big Bore
Model / REF:
728242
728243
728244
Serial Numbers:
766018
7179
7238
7273
7418
7467
7608
7634
7618
7801
7925
75111
75045
75119
75035
75132
750019
76023
7271
7979
76234
750003
7878
76054
760019
76135
76230
76147
76171
760057
760058
76270
760075
UDI:
00884838095168
00884838059450

Recall Number Z-2597-2025

Product: Philips Brilliance iCT
Model / REF:
728306
Serial Numbers (210):
100068
100188
100241
100288
100332
100365
100461
85007
85016
100657
100682
100686
100779
100832
100783
100775
100788
100807
100828
100816
85136
85153
100043
100038
100082
100074
100081
100097
100098
100119
100111
100113
100123
100130
100133
100222
100141
100134
100160
100157
100150
100158
100180
100161
100173
100215
100064
100117
100247
100172
UDI:
00884838059474

Recall Number Z-2598-2025

Product: Philips Brilliance iCT SP
Model / REF:
728311
Serial Numbers:
200016
200024
200211
200041
200030
200060
200048
200069
200098
200097
200112
200136
200200
200209

Recall Number Z-2599-2025

Product: Philips Ingenuity CT Systems
Model / REF:
728321
728323
728326
Serial Numbers (285):
310033
310095
310098
333020
333135
52084
310005
310019
310030
310038
310050
310057
310053
310075
310126
310009
310101
310108
310157
310170
333024
310171
333061
333021
52007
52017
52039
333053
31001
333130
52025
52037
52056
333132
52063
333077
310288
310230
310221
310238
310294
310286
310233
310259
310283
310293
310262
310274
333092
333107
UDI:
00884838059498
00884838059504
00884838059511

Recall Number Z-2600-2025

Product: Philips IQon Spectral CT
Model / REF:
728332
Serial Numbers (81):
860088
860023
860077
860086
60019
860152
860215
60031
60123
60129
60152
860011
860049
860019
860008
860030
860025
860009
860022
860013
860024
860020
860036
860041
860046
860055
860058
860054
860073
860065
860070
860072
860066
860103
860076
860085
860095
860102
860101
860104
860175
860136
860117
860120
860121
860124
860125
860191
860131
860150
UDI:
00884838059542

Recall Number Z-2601-2025

Product: Philips Ingenuity Core128 / Elite China
Model / REF:
728324
Serial Numbers:
336821
337127
336823
336824
336828
336817
336952
336826
336847
336857
336876
336894
336948
336936
336947
337012
337074
337090
337116
337136
345016
345032
345099
345104
UDI:
00884838059863

Recall Number Z-2602-2025

Product: Philips Ingenuity CT Family Brazil
Model / REF:
728325
Serial Numbers:
338014
338028
338019

Recall Number Z-2603-2025

Product: Philips CT 6000
Model / REF:
728307
Serial Numbers:
87150
87169
87118
87168
87166
87164
UDI:
00884838104600

Recall Number Z-2604-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97468
Status: Active
Manufacturer: Philips North America Llc
Sold By: Hospitals; Medical Imaging Centers; Surgical Centers; Clinical Laboratories
Manufactured In: United States
Units Affected: 10 products (181 units; 73 units; 33 units; 210 units; 14 units; 285 units; 81 units; 24 units; 3 units; 6 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.