Lower risk Medical device recall · FDA · Published July 15, 2024

Philips Azurion X-ray System Software R1.0-R1.2 May Cause Imaging Loss

Philips recalls Azurion Interventional Fluoroscopic X-ray Systems with software versions R1.0, R1.1, or R1.2 due to potential loss of X-ray imaging functionality and longer cold restart times.

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

🇺🇸 FDA recall #Z-2534-2024Medical device Philips ›

Lower-risk recall

Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

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 with specific software versions. These systems may lose X-ray imaging functionality or take longer to restart, which could affect medical procedures. Read more at govinfonow.com/recall/54621-philips-azurion-x-ray-system-software-r1-0-r1-2.

Source Summary by GovInfoNow · govinfonow.com/recall/54621-philips-azurion-x-ray-system-software-r1-0-r1-2 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2534-2024

Cite this page

“Philips Azurion X-ray System Software R1.0-R1.2 May Cause Imaging Loss.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54621-philips-azurion-x-ray-system-software-r1-0-r1-2. Based on FDA recall #Z-2534-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2534-2024%22&limit=1).

The FDA announced on July 15, 2024, that Philips Medical Systems Nederland B.V. is recalling its Azurion Interventional Fluoroscopic X-ray Systems due to potential loss of imaging functionality and longer cold restart times. The agency issued recall number Z-2534-2024 for the voluntary Class II recall affecting 3,011 units distributed worldwide.

How to tell if you have it

Brand: Philips
Product: Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2
Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079
UPCs: 00884838085251, 00884838085268, 00884838085275, 00884838085282, 00884838085350, 00884838085367

The hazard

The recall addresses potential loss of imaging (X-ray) functionality and/or longer time to perform a cold restart on the Azurion Interventional Fluoroscopic X-ray System. The device is intended for image guidance in diagnostic, interventional, and minimally invasive surgery procedures.

Context

GovInfoNow's records show Philips Medical Systems Nederland B.V. has 58 other recalls on record since May 26, 2021. Recent similar recalls include a July 16, 2026 recall for two software-related issues affecting Azurion R2.2.10 Systems and another July 16, 2026 recall for potential loss of geometry movements. Other recent recalls of similar products include the Aug. 21, 2026 Philips Achieva 3.0T MRI recall for a software issue that may terminate scans, the Oct. 27, 2025 Philips Azurion R3.0 X-ray System recall for a missing SSD spacer risk, and the Aug. 6, 2026 Philips IntraSight Plus recall for a software error that may cause wrong patient diagnosis.

How to tell if you have this one

Check for model numbers 722063, 722064, 722067, 722068, 722078, or 722079 with software versions R1.0, R1.1, or R1.2. These systems are used for medical procedures like vascular and neuro surgeries.

Brand
Philips
Product
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your Philips Azurion system to see if it is R1.0, R1.1, or R1.2.
Contact Philips Support
Reach out to Philips for guidance on whether your system needs an update or repair.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam,…” 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 30 days after the firm started it.

Jul 15, 2024Firm started the recall
Aug 8, 2024FDA classified it Class II
Aug 14, 2024Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Philips recalls

Link to this recall

<a href="https://govinfonow.com/recall/54621-philips-azurion-x-ray-system-software-r1-0-r1-2">Philips Azurion X-ray System Software R1.0-R1.2 May Cause Imaging Loss (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-2534-2024 (July 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2534-2024 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.