HIGH

Philips Azurion Systems Recalled Due to Software Issues

Philips recalled 990 Azurion Systems on December 8, 2025, after nine software issues were identified. The defects may cause loss of X-ray functionality, system restarts, and other operational failures. Healthcare providers must stop using the devices immediately.

Quick Facts at a Glance

Recall Date
December 8, 2025
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

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: E-Mail

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About This Product

Philips Azurion Systems are advanced medical imaging devices used in healthcare settings for diagnostic procedures. They provide real-time imaging capabilities crucial for effective patient care.

Why This Is Dangerous

The identified software issues can lead to critical failures in the imaging process, potentially jeopardizing patient safety during medical examinations.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires immediate action from healthcare providers to avoid using malfunctioning equipment, which could disrupt patient care and diagnostic accuracy.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on your device
  2. Check if the model number matches the recalled list
  3. Review the recall notice for specific software version details

Where to find product info

The model number and software version can typically be found on the device's front panel or user manual.

What timeline to expect

Expect processing for refunds or replacements to take 4-6 weeks after contacting Philips.

If the manufacturer is unresponsive

  • Document all communication attempts with Philips
  • Reach out to your healthcare provider for assistance
  • File a report with the FDA if necessary

How to prevent similar issues

  • Regularly update software on medical devices
  • Follow maintenance schedules recommended by the manufacturer
  • Stay informed about recalls in the medical device industry

Documentation advice

Keep records of all correspondence regarding the recall, including emails and receipts for any related purchases.

Product Details

The recall involves Philips Azurion Systems R3.0, including models 722229, 722230, 722231, 722232, 722235, 722236, 722233, and 722234. The systems were distributed worldwide, including the US and various countries. These models were sold globally.

Key Facts

  • Recalled models include Azurion 3 M12, M15, Azurion 5 M12, M20, and Azurion 7 models
  • Nine software issues identified
  • Stop using devices immediately
  • Contact Philips for instructions

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 Classification

Product Details

Model Numbers
Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22
(01)00884838116726(21)15
(01)00884838116726(21)16
(01)00884838116726(21)6
(01)00884838116726(21)8
+15 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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