Lower risk Medical device recall · FDA · Published December 12, 2025

Philips Azurion System Software R3.1 May Cause Imaging Loss - Recall

Philips recalls Azurion system software version R3.1 due to potential loss of X-ray imaging and motorized movement. Affected models include Azurion 3 M12, 3 M15, 5 M12, 5 M20, 7 M12, 7 M20, and 7 B12 systems with specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1113-2026Medical device Philips ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 4-6 · Best, Netherlands

✎ GovInfoNow plain-language explainer

Philips is recalling Azurion system models with software version R3.1 because two software issues could cause loss of X-ray imaging, motorized movement, or incorrect images. This affects medical imaging equipment used in hospitals and clinics. Read more at govinfonow.com/recall/50465-philips-azurion-system-software-r3-1-may-cause-imaging-loss.

Source Summary by GovInfoNow · govinfonow.com/recall/50465-philips-azurion-system-software-r3-1-may-cause-imaging-loss · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1113-2026

Cite this page

“Philips Azurion System Software R3.1 May Cause Imaging Loss - Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50465-philips-azurion-system-software-r3-1-may-cause-imaging-loss. Based on FDA recall #Z-1113-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1113-2026%22&limit=1).

The FDA announced on Dec. 12, 2025, that Philips Medical Systems Nederland B.V. is recalling Philips Azurion systems with software version R3.1 due to potential loss of imaging functionality or motorized movement. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Philips
Product: Philips Azurion system, Software Version Number: R3.1
Model Numbers: 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236
System Product Names: Azurion 3 M12, Azurion 3 M15, Azurion 7 M12, Azurion 7 M20, Azurion 7 B12, Azurion 7 B20, Azurion 5 M12, Azurion 5 M20
UDI-DIs: 00884838099203, 00884838099210, 00884838099241, 00884838099258, 00884838099265, 00884838099272, 00884838099227, 00884838099234, 00884838116726, 00884838116733, 00884838116740, 00884838116757, 00884838116764, 00884838116771, 00884838116788, 00884838116801
Units affected: 228 units

The hazard

The recall cites two software issues that may result in loss of imaging (X-ray) functionality, loss of motorized movement, incorrect image content, or loss of data. Issue 1 involves the system remaining in continuous restart mode after start-up. Issue 2, applicable only to systems with Poly-G3 frontal stand, is a Longitudinal Position Error.

Context

GovInfoNow's records show PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 58 other recalls on record since 2021-05-26. Other recent recalls of similar products include Philips Medical Systems (2026-07-16), Philips (2026-07-16), and Philips Medical Systems (2026-06-29). Other recent recalls of similar products include Philips Achieva 3.0T MRI Recalled: Software Issue May Terminate Scans (2026-08-21), Philips Azurion R3.0 X-ray System Recall: Missing SSD Spacer Risk (2025-10-27), and Philips Incisive CT Recall: Unstable Sensor May Cause Incomplete Scans (2025-12-03).

How to tell if you have this one

Check for the model numbers 722221-722236 listed in the recall. The system product names include Azurion 3 M12, 3 M15, 5 M12, 5 M20, 7 M12, 7 M20, and 7 B12. Specific serial numbers are provided for each model.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version by checking the device settings or documentation. If it shows version R3.1, it is affected.

How this recall unfolded

Recall timeline

FDA published this recall 47 days after the firm started it.

Dec 12, 2025Firm started the recall
Jan 16, 2026FDA classified it Class II
Jan 28, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50465-philips-azurion-system-software-r3-1-may-cause-imaging-loss">Philips Azurion System Software R3.1 May Cause Imaging Loss - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1113-2026 (December 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1113-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.