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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 Zenition 50 and 70 Mobile C-Arm Systems Recalled for Fuse Failure

Agency Publication Date: November 12, 2024
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Summary

Philips Zenition 50 and Zenition 70 Mobile C-Arm Systems are being recalled due to a potential hardware failure where a fuse on the Mains Control Unit board may blow. This issue can occur while the system is starting up or during an active medical procedure, affecting 3,233 units (986 Zenition 50 and 2,247 Zenition 70 units). If the fuse blows, the system will lose power and shut down, which could interrupt surgical or diagnostic procedures. No injuries or incidents have been reported in the provided documentation.

Risk

The Mains Control Unit board fuse can fail, causing an unexpected power loss during use. If this occurs during a medical procedure, the loss of imaging could lead to delays or complications for the patient.

What You Should Do

  1. This recall affects Philips Zenition 50 (Model 718096) and Zenition 70 (Model 718133) Mobile C-Arm Systems used in medical imaging.
  2. Identify if your device is affected by checking the model number and serial number on the device identification label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction of the Mains Control Unit board.
  4. Call the FDA's Center for Devices and Radiological Health (CDRH) at 1-888-463-6332 for more information about this medical device recall.

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 Zenition 50
Model / REF:
718096
Serial Numbers (1009):
792
1762
1763
1748
236
1310
1311
1764
1078
1759
1760
1761
317
1297
75
73
939
1517
877
1857
50
1286
296
580
147
477
1681
1288
875
1309
466
467
1192
1369
386
387
52
51
1689
1691
1692
1807
4
1690
1693
415
1561
1269
432
798
UDI:
00884838091535

Quantity: 986 units affected globally.

Product: Philips Zenition 70
Model / REF:
718133
Serial Numbers (2312):
420
4093
2851
3947
2571
4211
3325
3326
2324
3665
491
480
579
580
581
582
4138
71
3657
3660
3889
669
670
671
233
3416
4351
4352
4353
4355
3971
3972
4387
4278
2880
3366
4062
4063
3374
4201
4083
1290
3894
932
933
4309
1796
3355
3680
4156
UDI:
00884838091528

Quantity: 2,247 units affected globally.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95579
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Philips Medical Systems; Authorized Medical Device Distributors
Manufactured In: Netherlands
Units Affected: 2 products (986 units (156 US, 29 Canada, 801 ROW); 2,247 units (582 US, 84 Canada, 1,581 R.O.W.))
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.