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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 MEDICAL SYSTEMS NEDERLAND B.V.: Azurion X-Ray Systems Recalled for Software Issue Causing System Restarts

Agency Publication Date: January 26, 2024
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Summary

Philips Medical Systems is recalling 1,799 Azurion Interventional fluoroscopic x-ray systems in the United States (and 5,747 units worldwide) because of a software issue that causes the system to continuously restart. This defect leads to a sudden loss of imaging functionality and patient data. If the restart occurs during a surgical or diagnostic procedure, it can result in significant delays or the need to stop the medical procedure entirely. Consumers and healthcare facilities should verify their model and software version against the affected list and contact the manufacturer for technical support.

Risk

The software failure triggers an infinite reboot loop that prevents medical staff from seeing live x-ray images or accessing patient data during critical procedures. This can lead to procedural delays or total abortion of surgery, potentially increasing the risk of complications for patients undergoing interventional treatments.

What You Should Do

  1. Identify if your medical facility uses a Philips Azurion system with software versions R1.0, R1.1, R1.2, R2.0, R2.1, or R2.2.
  2. Check your system's model and UDI-DI number against affected models: Azurion 3M12, 3M15, 5M12, 5M20, 7B12/12, 7B20/15, 7M12, and 7M20.
  3. Verify the specific model number on the device label, looking for numbers such as 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, 722224, or 722280.
  4. Contact your healthcare provider or Philips Medical Systems Nederland B.V. immediately for further instructions and to schedule any necessary software updates or repairs.
  5. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

System performance issue correction.

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

Affected Products

Product: Philips Azurion 3M12
Model / REF:
722063
722221
UPC Codes:
00884838085275
00884838099203
00884838101890
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 3M15
Model / REF:
722064
722222
UPC Codes:
00884838085282
00884838099210
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 5M12
Model / REF:
722227
UPC Codes:
00884838099227
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 5M20
Model / REF:
722228
UPC Codes:
00884838099234
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 7B12/12
Model / REF:
722067
722225
UPC Codes:
00884838059290
00884838064775
00884838085350
00884838099265
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 7B20/15
Model / REF:
722068
722226
UPC Codes:
00884838059207
00884838064775
00884838085367
00884838099272
00884838101883
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 7M12
Model / REF:
722078
722223
UPC Codes:
00884838085251
00884838099241
00884838101890
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 7M20
Model / REF:
722079
722224
UPC Codes:
00884838059184
00884838059191
00884838059207
00884838059221
00884838059290
00884838064775
00884838085268
00884838086777
00884838099258
00884838101883
00884838101890
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Product: Philips Azurion 3 M15 (China)
Model / REF:
722280
UPC Codes:
00884838085282
00884838099210
00884838103276
Date Ranges: Software Versions R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93755
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: Authorized Medical Device Distributors
Manufactured In: Netherlands
Units Affected: 1,799 US; 5,747 OUS
Distributed To: Nationwide
Agency Last Updated: February 28, 2024

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.