FDA-Device2026-04-22Class IIPROCESSING DEFECT

Philips AneurysmFlow software recalled for unreliable aneurysm flow measurement

FALSE CLAIMSNationwide distributionMedical devices

What this means

Philips AneurysmFlow is software used by doctors to help evaluate aneurysm treatment with flow diverter stents. The software's Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably predict whether the aneurysm is successfully closed, but doctors may be using it to make treatment decisions based on the user manual.

If your hospital or clinic uses Philips AneurysmFlow (Model 001015), contact Philips Medical Systems for guidance on this software issue
Do not rely solely on the MAFA ratio measurement when making clinical decisions about aneurysm treatment
Review affected patient cases with your clinical team

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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, Germany, Greece, Indonesia, Iraq, Italy, Japan, Kuwait, Latvia, Macao, Maldives, Mongolia, Morocco, New Zealand, Nicaragua, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Switzerland, TURKEY, Ukraine, Utd.Arab.Emir., Uzbekistan, Vietnam.

Affected count

1,033 units

Manufactured in

Veenpluis 4-6, N/A, Best, N/A, Netherlands

Products

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1805-2026

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