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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 M20 FlexArm Recalled for Connectivity Loss During Medical Procedures

Agency Publication Date: January 30, 2024
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Summary

Philips Medical Systems Nederland B.V. is recalling 28 Azurion 7 M20 FlexArm systems because a software issue can cause a total loss of connectivity between the FlexArm imaging component and the Maquet Magnus table. This defect affects 9 systems in the United States across several states, 1 in Canada, and 18 globally. If connectivity is lost during a surgical or interventional procedure, it could lead to delays or inability to properly position the equipment, which may impact patient care. Consumers should contact Philips for guidance and to facilitate the necessary software corrective actions.

Risk

The software error causes the imaging arm and the patient table to stop communicating, which may prevent the equipment from moving safely or accurately during a procedure. This failure could result in procedural delays or the need to transfer a patient to another room in the middle of a medical intervention.

What You Should Do

  1. Identify if your facility is using an Azurion 7 M20 FlexArm system with Software version R2.x and a Maquet Magnus Table with Software version 05.02.12.
  2. Check your system for the following System Codes and Serial Numbers: (1) System Code 722079 (Serial Numbers: 1086, 1392, 703615, 1079, 743, 703456, 1248) or (2) System Code 722224 (Serial Numbers: 1337, 1249, 1925, 1250, 468, 379, 647, 633, 1534, 887, 1349, 280, 969, 197, 1177, 455, 3, 2611, 2716, 606, 2025).
  3. Verify the Unique Device Identifier (UDI) matches either 00884838085268 or 00884838099258.
  4. Immediately contact your Philips representative or healthcare provider to discuss instructions for the software fix and how to manage use until the update is applied.
  5. For further information or technical support, contact Philips Medical Systems Nederland B.V. at their headquarters or through your local service representative.
  6. Call the FDA's medical device hotline for additional questions at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/software update

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
System Code: 722224
UPC Codes:
00884838085268
00884838099258
Lot Numbers:
Serial Number: 1086
Serial Number: 1392
Serial Number: 703615
Serial Number: 1079
Serial Number: 743
Serial Number: 703456
Serial Number: 1248
Serial Number: 1337
Serial Number: 1249
Serial Number: 1925
Serial Number: 1250
Serial Number: 468
Serial Number: 379
Serial Number: 647
Serial Number: 633
Serial Number: 1534
Serial Number: 887
Serial Number: 1349
Serial Number: 280
Serial Number: 969
Serial Number: 197
Serial Number: 1177
Serial Number: 455
Serial Number: 3
Serial Number: 2611
Serial Number: 2716
Serial Number: 606
Serial Number: 2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93721
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Philips direct sales; authorized medical equipment distributors
Manufactured In: Netherlands
Units Affected: 28 systems (9 US, 1 Canada, 18 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.