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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 North America Llc: Philips Imaging Systems Recalled Due to Risk of Ceiling Units Falling

Agency Publication Date: November 8, 2023
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Summary

Philips North America Llc is recalling 837 imaging systems across several models, including CombiDiagnost R90 and various DigitalDiagnost versions, because components suspended from the ceiling may fail and fall. This defect can lead to the heavy equipment unexpectedly dropping during use. No specific injuries were reported in the data, but the recall covers systems distributed nationwide. Consumers should contact their healthcare provider or Philips for information on inspections and necessary repairs.

Risk

The ceiling-mounted components of these radiography and fluoroscopy systems can fail structurally, causing the equipment to fall. This poses a significant risk of impact injuries to patients or medical staff located beneath the suspended units.

What You Should Do

  1. Identify if your facility uses any of the affected systems, such as the CombiDiagnost R90, ProxiDiagnost N90, EasyDiagnost Eleva DRF, or various DigitalDiagnost 4 and C90 models.
  2. Check your device serial number against the extensive list provided in the recall notice to confirm if your specific unit is affected.
  3. Inspect the ceiling suspension components of your imaging system for any visible signs of wear, loosening, or instability.
  4. Contact Philips North America Llc directly at their Cambridge, Massachusetts headquarters or through their official support channels to schedule a safety inspection and repair.
  5. For medical staff, exercise extreme caution when positioning or moving ceiling-suspended units until they have been cleared by a service technician.
  6. Consult with your healthcare provider or facility's biomedical engineering department to discuss the safety of the device and any necessary clinical alternatives.
  7. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices for additional information or to report any incidents related to this equipment.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Safety Inspection and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Model / REF:
709030
709031
Lot Numbers:
SN17000014
10000020
SN17000130
SN17000123
SN18000021
SN18000001
SN18000075
SN18000002
10000004
SN17000144
SN17000140
SN18000003
SN18000063
SN18000018
SN18000022
SN18000041
SN18000031
10001097
10000056
28
10000184
SN19000018
SN19000006
SN19000040
SN19000001
SN19000041
10000051
10000000
10000087
10001095
10000122
10001001
10000145
10000152
10000190
10001076
SN17000153
10001054
10001087
10001086
10001159
10001109
10001114
10001171
10001194
10001193
Product: DigitalDiagnost 4 Chest/Emergency
Model / REF:
712029
712033
Lot Numbers:
SN15000409
SN19000272
SN19000213
10001077
SN20000097
SN16000074
SN15000238
SN16000075
SN15000367
SN18000428
SN17000318
SN18000309
SN18000204
Product: DigitalDiagnost 4 Flex/Value
Model / REF:
712028
712227
712032
Lot Numbers (92):
SN15000418
SN15000397
SN18000410
SN18000253
SN18000339
SN18000332
SN18000448
SN18000306
SN18000397
SN18000366
SN18000391
SN18000431
SN19000191
SN19000119
SN19000217
SN19000109
SN19000260
SN20000159
SN19000328
SN20000372
SN20000277
SN20000003
SN20000052
SN19000321
SN20000039
SN20000121
SN18000024
SN15000304
SN15000283
SN15000252
SN15000255
SN18000274
SN16000009
SN16000036
SN16000262
SN17000002
SN16000249
SN17000357
SN18000035
SN17000389
SN17000058
SN16000008
SN17000122
SN17000027
SN17000125
SN17000083
SN17000103
SN17000110
SN17000171
SN17000241
Product: DigitalDiagnost 4 High Performance
Model / REF:
712027
712031
712226
Lot Numbers (366):
SN15000410
SN15000417
SN15000435
SN15000265
SN15000185
SN15000110
SN18000276
SN18000158
SN19000178
SN18000227
SN18000256
SN18000228
SN18000257
SN18000247
SN18000252
SN18000238
SN19000195
SN19000101
SN19000180
SN18000283
SN18000299
SN19000337
SN18000305
SN19000019
SN18000224
SN18000248
SN18000223
SN18000394
SN18000286
SN19000247
SN18000232
SN19000292
SN18000282
SN18000296
SN20000083
SN18000266
SN18000335
SN18000441
SN19000147
SN18000298
SN18000295
SN18000427
SN18000450
SN19000300
SN19000034
SN18000271
SN19000080
SN19000060
SN18000440
SN19000136
Product: DigitalDiagnost C90 Flex/Value/Chest/ER
Model / REF:
712035
Lot Numbers:
10000009
10000010
10000003
10000004
10000002
10000001
10000053
10001042
10001044
10001125
10001113
10001111
10001112
10001109
10001110
10001114
21862107
10001130
21862103
21862101
21862100
22860370
21862123
21862126
22860323
22860045
22860317
22860316
22860318
22860342
22860357
23860320
23860316
Product: DigitalDiagnost C90 High Performance
Model / REF:
712034
Lot Numbers (143):
SN19000013
10000203
10000008
10000030
10000043
10000037
19861128
19861129
10000064
19861143
10000024
SN10001001
10001043
10000077
10000076
10000104
10000102
10000126
10000185
10001084
22860136
10001144
19861160
10000198
22860421
SN10001002
10000212
19861136
10001057
19861165
10000196
19861199
19861197
19861215
19861233
10001106
10001154
19861265
10001104
10001040
10001042
10001019
10001018
10001052
21861498
10001124
21861529
10001114
10001126
21861493
Product: DigitalDiagnost C90 Release 3
Model / REF:
712025
Lot Numbers:
SN13000328
Product: DigitalDiagnost C90 Release 3.1
Model / REF:
712026
Lot Numbers:
SN14000197
SN14000260
Product: EasyDiagnost Eleva DRF, Release 5
Model / REF:
706050
Lot Numbers:
SN17000007
SN16000025
SN15000051
SN15000049
SN15000056
SN15000055
SN16000046
SN16000041
SN16000011
SN16000029
SN16000024
SN16000028
SN16000042
SN16000030
SN16000044
SN16000051
SN17000001
SN16000049
SN16000043
SN16000061
SN17000003
SN16000052
SN16000056
SN17000011
SN17000002
SN17000025
SN17000006
SN17000031
SN17000028
SN17000038
SN17000022
SN18000009
SN17000035
SN17000027
SN17000026
SN18000004
SN18000008
SN18000002
SN18000001
SN15000014
Product: ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Model / REF:
706100
706110
Lot Numbers (98):
SN18000019
SN18000002
721815121706
10000015
SN18000014
20000070
SN19000007
10000035
10000011
SN18000021
SN19000002
SN19000001
10000021
20000054
SN19000006
SN19000011
SN19000012
SN19000005
10000051
20000078
10000050
20000045
10000008
SN19000018
10000017
10000045
SN19000017
SN19000014
10000013
10000010
10000031
10000030
10000018
10000024
10000020
10000025
10000026
10000028
SN10001008
10000036
10000037
10000043
20000026
SN10001004
10000052
20000051
10001028
10000040
20000086
20000052

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93200
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized Philips medical equipment distributors; Direct medical facility sales
Manufactured In: United States
Units Affected: 10 products (46 units; 13 units; 92 units; 366 units; 33 units; 143 units; 1 unit; 2 units; 40 units; 101 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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.