Use caution Medical device recall · FDA · Published December 12, 2023

Philips Azurion X-Ray System Recall: Imaging Issues May Cause Procedure Delays

Philips recalls Azurion 3M12, 3M15, 5M12, 5M20, 7B12/12, 7B20/15, 7M12, and 7M20 models due to potential imaging restarts during procedures, risking delays or aborted medical procedures.

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

🇺🇸 FDA recall #Z-0835-2024Medical device Philips ›

Use caution until it’s fixed

System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Philips is recalling certain Azurion interventional fluoroscopic x-ray systems because they may restart unexpectedly, causing delays or aborted procedures during medical treatments. This affects specific model numbers and software versions. Read more at govinfonow.com/recall/56566-philips-azurion-x-ray-system-recall-imaging-issues-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/56566-philips-azurion-x-ray-system-recall-imaging-issues-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0835-2024

Cite this page

“Philips Azurion X-Ray System Recall: Imaging Issues May Cause Procedure Delays.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56566-philips-azurion-x-ray-system-recall-imaging-issues-may-cause. Based on FDA recall #Z-0835-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0835-2024%22&limit=1).

The FDA announced on 2023-12-12 that Philips Medical Systems Nederland B.V. is voluntarily recalling its Azurion interventional fluoroscopic x-ray systems due to a hazard of continuous system restarts. The recall affects units distributed worldwide, including those in the United States.

How to tell if you have it

Brand: Philips
Product: Philips Azurion system, Interventional fluoroscopic x-ray system
Model Numbers: Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280
UDI-DI Codes: Azurion 3M12 - 00884838085275, 00884838099203, 00884838101890; Azurion 3M15 - 00884838085282, 00884838099210; Azurion 5M12 - 00884838099227; Azurion 5M20 - 00884838099234; Azurion 7B12/12 - 00884838059290, 00884838064775, 00884838085350, 00884838099265; Azurion 7B20/15 - 00884838059207, 00884838064775, 00884838085367, 00884838099272, 00884838101883; Azurion 7M12 - 00884838085251, 00884838099241, 00884838101890; Azurion 7M20 - 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838099258, 00884838101883, 00884838101890; Azurion 3 M15 (China) - 00884838085282, 00884838099210, 00884838103276
Software Versions: R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Distribution: Worldwide - US Nationwide distribution

The hazard

According to the FDA, the system may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

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 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 model numbers Azurion 3M12, 3M15, 5M12, 5M20, 7B12/12, 7B20/15, 7M12, or 7M20 with software versions R1.0 through R2.2. The system was sold with specific serial numbers and UDI-DI codes listed in the recall notice.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Model
Identify your Philips Azurion system model and software version to confirm if it's affected by the recall.
Contact Philips Support
Reach out to Philips customer support for guidance on next steps if your system is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 57 days after the firm started it.

Dec 12, 2023Firm started the recall
Jan 26, 2024FDA classified it Class II
Feb 7, 2024Published 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/56566-philips-azurion-x-ray-system-recall-imaging-issues-may-cause">Philips Azurion X-Ray System Recall: Imaging Issues May Cause Procedure Delays (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-0835-2024 (December 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0835-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.