Philips recalls AneurysmFlow software (model 001015) due to potential unreliable Mean Aneurysm Flow Amplitude (MAFA) ratio for aneurysm occlusion predictions. This could lead to incorrect clinical decisions during stent treatment.
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Philips is recalling AneurysmFlow software (model 001015) because its Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably predict aneurysm occlusion after Flow Diverter Stent treatment. This could cause incorrect clinical decisions if doctors rely on the MAFA ratio for treatment outcomes.
The MAFA ratio in AneurysmFlow software does not provide reliable prognostic information about whether an aneurysm will close after Flow Diverter Stent treatment. Philips states that despite being stated in the IUF (Interventional User's Guide), this ratio is being relied on for clinical decisions, which could lead to incorrect treatment outcomes.
Patients using Philips AneurysmFlow software with Philips interventional X-ray systems (Allura or Azurion) for aneurysm treatment may be affected. The risk is low as this is a software issue that does not cause immediate harm but could lead to incorrect treatment decisions.
Check for model number 001015 on the software. The software is used with Philips Allura or Azurion X-ray systems (model numbers listed in the recall) for aneurysm treatment. The Allura and Azurion systems themselves are not affected by this recall.
Look for model number 001015 on the AneurysmFlow software.
No, the Philips Allura and Azurion X-ray systems themselves are not affected by this recall. The recall only applies to the AneurysmFlow software used with these systems.
Check if your AneurysmFlow software has model number 001015. If it does, contact Philips for guidance on next steps, though the recall does not specify a remedy.
Philips states that the software issue does not cause immediate harm but could lead to incorrect clinical decisions during aneurysm treatment. The risk is considered low as it does not involve physical harm from the software itself.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1805-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-1805-2026 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.
