Philips recalls Azurion 7 Series and Allura Xper R9 software versions R1.2 and R2.0 due to a defect causing digital subtraction angiography images to display without subtraction.
Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
Philips is recalling specific software versions for their Azurion 7 Series and Allura Xper R9 systems. The software defect causes digital subtraction angiography (DSA) images to display without subtraction, which could lead to inaccurate medical imaging during procedures.
The software defect causes digital subtraction angiography (DSA) images to display without subtraction. This means the images may not properly isolate blood vessels from surrounding tissues, potentially leading to inaccurate diagnosis or treatment decisions during endovascular procedures.
Medical professionals using Philips Azurion 7 Series or Allura Xper R9 systems with the affected software versions. Patients undergoing procedures with these systems may be at risk if the software defect causes inaccurate imaging.
Check if your system has Azurion 7 Series software versions R1.2 or R2.0, or Allura Xper R9 software upgraded to Azurion 1.2 M20. Look for the specific system codes listed in the recall notice.
Verify your software version by checking the system codes provided in the recall notice.
Azurion 7 Series software versions R1.2 and R2.0, and Allura Xper R9 software upgraded to Azurion 1.2 M20.
Check your system codes against the list provided in the recall notice, which includes specific Azurion and Allura model numbers.
The recall does not specify a remedy, so you should check with Philips for guidance on next steps.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1145-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-1145-2020 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.
