Philips recalls Azurion 7 M20 software with Azurion R2.0 system for incorrect X-ray overlays if L-arm isn't repositioned during live guidance. Affected units have specific serial numbers.
When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.
Philips is recalling Azurion 7 M20 software used with Azurion R2.0 systems because moving the L-arm away from the scan position before starting live guidance can cause incorrect X-ray overlays. This could lead to inaccurate needle paths during procedures.
When the L-arm is moved away from the initial scan position before starting live guidance, the software shows a warning but doesn't stop the procedure. This can cause incorrect X-ray overlays and needle paths during procedures.
Medical professionals using the Azurion 7 M20 software with Azurion R2.0 systems in the U.S., Canada, and other regions. Those performing interventional procedures are most at risk.
Check for serial numbers: U.S. units have 637, 200, 909, 1276, 1309, 987; Canada has 1016; other regions have listed numbers. The software is part of Azurion 7 M20 with Azurion R2.0 systems.
Verify if your system uses Azurion 7 M20 software with Azurion R2.0 systems by checking the serial numbers listed in the recall notice.
The software shows a warning when the L-arm is moved away from the scan position but doesn't prevent incorrect X-ray overlays during live guidance.
The recall notice doesn't specify a remedy, so check with Philips for guidance on next steps.
The recall states incorrect overlays could occur, but no specific injury risk is mentioned.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1809-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-1809-2020 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.
