Use caution Medical device recall · FDA · Published May 28, 2025

Philips Azurion R1.x/R2.x Medical Systems Recall: Risk of Therapy Delay in Critical Cases

Philips recalls Azurion R1.x and R2.x medical imaging systems with specific model numbers due to software issues that may delay critical treatments, risking serious health outcomes like death in urgent medical scenarios.

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

🇺🇸 FDA recall #Z-1969-2025Medical device Philips ›

Use caution until it’s fixed

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

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 R1.x and R2.x medical imaging systems with certain model numbers because a software problem could delay critical treatments. This delay might cause serious health risks, including death, for patients needing urgent care like stroke or heart attacks. Read more at govinfonow.com/recall/52211-philips-azurion-r1-x-r2-x-medical-systems-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52211-philips-azurion-r1-x-r2-x-medical-systems-recall-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1969-2025

Cite this page

“Philips Azurion R1.x/R2.x Medical Systems Recall: Risk of Therapy Delay in Critical Cases.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52211-philips-azurion-r1-x-r2-x-medical-systems-recall-risk. Based on FDA recall #Z-1969-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1969-2025%22&limit=1).

The FDA announced on May 28, 2025, that Philips is recalling Azurion R1.x and R2.x systems due to a software issue that may cause loss of X-ray functionality. This defect could delay therapy for patients undergoing urgent interventions. Owners should contact Philips for remedy details.

How to tell if you have it

Brand: Philips
Product: Azurion R1.x and R2.x systems
Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722281, 722282
Units affected: 9,707

The hazard

A software issue in the internal communication between system software and X-ray generator firmware may cause loss of imaging functionality. The FDA stated this could result in a delay of therapy, potentially leading to serious adverse health outcomes or death during complex interventions for conditions like acute ischemic stroke or life-threatening bleeds.

Context

GovInfoNow's records show Philips Medical Systems Nederland B.V. has had 58 other recalls on record since May 26, 2021. Recent similar recalls include a July 16, 2026 recall for Azurion R2.2.10 Systems regarding potential image quality degradation and another July 16, 2026 recall for Philips software issues affecting geometry movements. Other recent recalls of similar products include the August 21, 2026 Philips Achieva 3.0T MRI Recall for a software issue that may terminate scans, the July 31, 2026 Philips PIC iX Essentials Software Freeze recall for patient data issues, and the August 7, 2026 Philips Brilliance CT 64 Medical Scanner Recall for an unintended radiation risk.

How to tell if you have this one

Check if your system has model numbers 722063 through 722282. The software version is not specified, but the system is affected across all versions. Note that some model numbers are not sold in the U.S.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Model
Identify your system's model number from the list provided in the recall notice.
Contact Philips Support
Reach out to Philips 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 distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria,…” 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 21 days after the firm started it.

May 28, 2025Firm started the recall
Jun 12, 2025FDA classified it Class II
Jun 18, 2025Published 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/52211-philips-azurion-r1-x-r2-x-medical-systems-recall-risk">Philips Azurion R1.x/R2.x Medical Systems Recall: Risk of Therapy Delay in Critical Cases (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-1969-2025 (May 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1969-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.