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.
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.
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.
The system may restart continuously due to a software issue, which can cause imaging functionality to fail. If this happens during a medical procedure, it may lead to delays or the need to abort the procedure entirely.
Healthcare facilities using Philips Azurion systems with the affected model numbers and software versions are most at risk. Patients undergoing procedures with these systems may experience delays or aborted treatments.
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.
Identify your Philips Azurion system model and software version to confirm if it's affected by the recall.
Reach out to Philips customer support for guidance on next steps if your system is affected.
The recall includes Azurion 3M12, 3M15, 5M12, 5M20, 7B12/12, 7B20/15, 7M12, and 7M20 models with software versions R1.0 through R2.2.
The system may restart continuously due to a software issue, which can cause imaging functionality to fail during procedures, potentially leading to delays or aborted treatments.
No, but healthcare facilities should monitor for restarts and contact Philips if they experience issues during procedures.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0835-2024 — Philips Philips Hello, I own a Philips that is covered by recall Z-0835-2024 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.
