HIGH

Philips Azurion System Recalled Due to Software Malfunction

Philips recalled 228 Azurion systems on December 12, 2025, due to software issues that may cause loss of X-ray functionality. The problems can result in incorrect image content and motorized movement failure. Affected devices were distributed internationally across multiple countries.

Quick Facts at a Glance

Recall Date
December 12, 2025
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL

Hazard Information

Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

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 Philips Azurion system is used in medical environments for X-ray imaging and interventional procedures. It provides advanced imaging capabilities essential for healthcare providers.

Why This Is Dangerous

The identified software issues can lead to critical failures in imaging and motorized functions, impacting patient care and safety during procedures. Continuous restart mode and longitudinal position errors may obstruct timely medical interventions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare providers who rely on the Azurion system for accurate imaging. The urgency is high, and immediate action is required to avoid potential risks.

Practical Guidance

How to identify if yours is affected

  1. Check the model number of your Philips Azurion system against the recalled models.
  2. Verify the software version to see if it is R3.1.
  3. Look for the serial number on the device to confirm if it is affected.

Where to find product info

Model numbers and serial numbers can typically be found on the back or bottom of the device, or in the user manual.

What timeline to expect

Expect 4-6 weeks for processing of refunds or replacements once initiated with Philips.

If the manufacturer is unresponsive

  • Document all communication attempts with Philips.
  • Reach out to a healthcare regulatory body for further assistance if Philips does not respond.

How to prevent similar issues

  • Inquire about software updates and safety certifications before purchasing medical devices.
  • Regularly check for recalls and safety notices from manufacturers.
  • Ensure proper training for staff on the use of medical devices.

Documentation advice

Keep records of your device’s model and serial numbers, any communications with Philips, and copies of the recall notice.

Product Details

The recall involves Philips Azurion systems with software version R3.1. Affected model numbers include 722221, 722222, 722223, 722224, 722225, 722226, and 722227. The devices were distributed internationally.

Key Facts

  • 228 units recalled
  • Software Version: R3.1
  • International distribution
  • Issues with imaging functionality
  • Potential for incorrect image content

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 Number: R3.1
(1) Model Number: 722221
System Product Name: Azurion 3 M12
UDI-DI: 00884838099203
Serial Numbers: (2) Model Number: 722222
+15 more
Affected States
Nationwide
Report Date
January 28, 2026
Recall Status
ACTIVE

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