Philips AneurysmFlow Software Recall: Unreliable Flow Amplitude Ratio Risk
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.
Lower-risk recall
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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/49670-philips-aneurysmflow-software-recall-unreliable-flow-amplitude-ratio-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/49670-philips-aneurysmflow-software-recall-unreliable-flow-amplitude-ratio-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1805-2026
Cite this page
“Philips AneurysmFlow Software Recall: Unreliable Flow Amplitude Ratio Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49670-philips-aneurysmflow-software-recall-unreliable-flow-amplitude-ratio-risk. Based on FDA recall #Z-1805-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1805-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Philips- Product
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to- Category
Medical device
What to do — step by step
Check Software Model
Look for model number 001015 on the AneurysmFlow software.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bnis insted Us Instas instes, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Estonia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1805-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1805-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.