Philips Medical Systems Nederland B.v. Veenpluis 4-6 Best Netherlands: System, Image Processing, Radiological
AneurysmFlow Recall Summary Philips is recalling AneurysmFlow, a software tool used with interventional X-ray systems to help assess aneurysm treatment outcomes. The software's Mean Aneurysm Flow Amplitude (MAFA) ratio does not provide reliable information about whether aneurysms are properly sealed after Flow Diverter Stent treatment, but clinicians may be using it to make treatment decisions based on the user instructions. This recall affects hospitals and medical facilities worldwide, including all U.S. states.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
- Product
- 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.
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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, Germany, Greece, Indonesia, Iraq, Italy, Japan, Kuwait,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c5542f6f-825c-4cbe-a075-9a81f1a02856