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Philips Azurion R3.1 Software Recall

Philips Azurion system; Software Version Number: R3.1;

Updated December 12, 2025

Philips Azurion systems running Software Version R3.1 have two software issues that can cause loss of X-ray imaging, loss of motorized movement, or incorrect images. One issue may trap the system in continuous restart mode; the other affects systems with a Poly-G3 frontal stand and causes positioning errors.

Is the PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled? Yes. This product was recalled by FDA on December 12, 2025. Details below.

What is recalled

Philips Azurion system with Software Version Number R3.1, manufactured by Philips Medical Systems Nederland B.V.

Am I affected

You're affected if you operate or own a Philips Azurion system running Software Version R3.1. Check your system's software version in the system settings. If your system has a Poly-G3 frontal stand, you may also experience longitudinal positioning errors.

What to do right now

Contact Philips Medical Systems immediately for a software update or further instructions. Do not use the system if it enters continuous restart mode or if imaging functionality is lost until you receive guidance from Philips.

The hazard

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.

Brands affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1113-2026
Classification
Class II
Recalled
December 12, 2025
Read the official notice

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