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.
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).
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.
A software issue causes the system to lose X-ray imaging capability during specific medical procedures. This delay in imaging could prevent timely treatment for life-threatening conditions, such as strokes or heart attacks, potentially leading to death.
Healthcare facilities using Philips Azurion R1.x or R2.x systems with the listed model numbers are most at risk. Patients undergoing urgent procedures like strokes or heart attacks could face serious health consequences if the system malfunctions.
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.
Identify your system's model number from the list provided in the recall notice.
Reach out to Philips for guidance on next steps if your system is affected.
A software issue in the internal communication between the system software and X-ray generator firmware can cause loss of imaging functionality, potentially delaying critical treatments.
The delay in imaging could result in serious health outcomes, including death, especially for patients needing urgent care like strokes or heart attacks.
Yes, model numbers 722063 through 722282 are affected, though some are not sold in the U.S.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1969-2025 — Philips Philips Hello, I own a Philips that is covered by recall Z-1969-2025 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
