HIGH

Philips Azurion 7 B12 X-ray System Recalled for Foot Switch Imaging Failure (670 Units, 2026)

Philips recalls 670 Azurion 7 B12 X-ray imaging systems after finding the wired foot switch may fail to start imaging. The issue affects 106 US units and 564 in other countries. Hospitals should stop using the device and await manufacturer guidance.

Quick Facts at a Glance

Recall Date
March 3, 2026
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Azurion 7 B12 is an interventional X-ray imaging system used in hospital procedure rooms to guide minimally invasive interventions.

Why This Is Dangerous

A defect in the wired foot switch can prevent X-ray imaging from starting or cause intermittent operation, compromising procedural imaging.

Industry Context

This recall is not noted as part of a broader industry pattern.

Real-World Impact

Hospitals may experience imaging delays during procedures. The recall covers 670 units across many countries and requires immediate action to prevent workflow disruption and potential patient safety risk.

Practical Guidance

How to identify if yours is affected

  1. Identify System Code: 722067, 722225, 722235
  2. Check UDI: 00884838085350
  3. Review System Serial Numbers listed (e.g., 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278)

Where to find product info

On device data plate, user manual, or installation documentation for System Code, UDI, and Serial Numbers.

What timeline to expect

Remediation timelines vary by region; Philips will issue instructions and facilitate service or replacement as needed.

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • Contact Philips recall line or regional representative
  • If necessary, file a complaint with health authorities or the FDA
  • Document all communications and timelines

How to prevent similar issues

  • Verify system codes and UDIs during audits
  • Schedule service updates as recommended by Philips
  • Maintain up-to-date contact with the Philips service team and regional reps
  • Document all recalls and ensure unit culling from clinical use if advised

Documentation advice

Keep the recall notification, record all serial numbers and statuses, preserve any replacement or service tickets, and photograph data plates for records.

Product Details

Product: Azurion 7 B12 Interventional X-ray Imaging System System Codes: 722067, 722225, 722235 UDI: 00884838085350 System Serial Numbers: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278 Quantity recalled: 670 total (106 US, 564 OUS) Domestic distribution: Nationwide International distribution: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Côte d’Ivoire, Croatia,

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 670 total units recalled (106 US, 564 OUS)
  • System Codes: 722067, 722225, 722235
  • UDI: 00884838085350
  • System Serial Numbers: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123
  • Hazard: X-ray imaging may not start or may be intermittent when using the wired foot switch
  • Remedy: Stop using immediately; follow manufacturer instructions; contact Philips or healthcare team

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
722067
722225
722235
221
42
+16 more
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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