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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/Surgical Equipment

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 FlexArm Recalled for Software Bug Causing Loss of Movement

Agency Publication Date: January 30, 2024
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Summary

Philips Medical Systems is recalling 108 Azurion 7 M20 FlexArm systems because a software defect related to the date and time format can cause the FlexArm to lose connectivity with the Maquet Magnus surgical table. This software glitch results in an immediate loss of movement for both the robotic arm and the table during medical procedures. The recall affects 14 systems in the United States across several states and 94 systems internationally. Philips is initiating this voluntary correction to address the software communication error and restore reliable system movement.

Risk

If the software connection fails during a surgical or diagnostic procedure, the medical team will be unable to move the robotic arm or adjust the patient table. This sudden loss of mechanical control could delay critical medical treatments or prevent the physician from properly positioning the patient for imaging, potentially leading to patient injury or surgical complications.

What You Should Do

  1. Identify if your facility uses the Azurion 7 M20 FlexArm system with Software version R2.x and a Maquet Magnus Table with Software version 05.02.12.
  2. Check the system serial numbers against the affected list, including units such as 1005, 866, 1361, 952, 1241, 1169, 756, 703351, 1135, and others listed in the technical data.
  3. Verify if your system code is 722079 (UDI/DI 00884838085268) or 722224 (UDI/DI 00884838099258).
  4. Contact your healthcare provider or Philips Medical Systems directly to schedule the software update or correction required for this recall.
  5. Report any instances of connection loss or movement failure to Philips Medical Systems and the FDA.
  6. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.

Your Remedy Options

๐Ÿ“‹Other Action

Software correction or manufacturer instructions

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

Affected Products

Product: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Model / REF:
System Code: 722079
UDI/DI: 00884838085268
Lot Numbers:
Serial Number: 1005
Serial Number: 866
Serial Number: 1361
Serial Number: 952
Serial Number: 1241
Serial Number: 1169
Serial Number: 756
Serial Number: 703351
Serial Number: 1135
Serial Number: 1122
Serial Number: 824
Serial Number: 748
Serial Number: 630
Serial Number: 638
Serial Number: 703385
Serial Number: 812
Serial Number: 703346
Serial Number: 1303
Serial Number: 1313
Serial Number: 893
Serial Number: 768
Serial Number: 929
Serial Number: 703638
Serial Number: 1357
Serial Number: 703810
Serial Number: 934
Serial Number: 1202
Serial Number: 703461
Serial Number: 703706
Serial Number: 1172
Serial Number: 703959
Serial Number: 703845
Serial Number: 703705
Product: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Model / REF:
System Code: 722224
UDI/DI: 00884838099258
Lot Numbers (70):
Serial Number: 539
Serial Number: 395
Serial Number: 278
Serial Number: 134
Serial Number: 730
Serial Number: 252
Serial Number: 370
Serial Number: 36
Serial Number: 572
Serial Number: 645
Serial Number: 272
Serial Number: 495
Serial Number: 781
Serial Number: 62
Serial Number: 1388
Serial Number: 352
Serial Number: 1655
Serial Number: 690
Serial Number: 555
Serial Number: 895
Serial Number: 2165
Serial Number: 861
Serial Number: 60
Serial Number: 20
Serial Number: 648
Serial Number: 2231
Serial Number: 1778
Serial Number: 1431
Serial Number: 778
Serial Number: 477
Serial Number: 917
Serial Number: 1718
Serial Number: 388
Serial Number: 2042
Serial Number: 150
Serial Number: 764
Serial Number: 2036
Serial Number: 1421
Serial Number: 157
Serial Number: 879
Serial Number: 212
Serial Number: 144
Serial Number: 1463
Serial Number: 347
Serial Number: 575
Serial Number: 2187
Serial Number: 355
Serial Number: 2576
Serial Number: 1332
Serial Number: 424

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93734
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Authorized Medical Device Distributors; Direct Hospital Sales
Manufactured In: Netherlands
Units Affected: 108 systems (14 US, 1 Canada, 93 ROW)
Distributed To: Colorado, Florida, Illinois, Mississippi, Nevada, Texas

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.