Day

April 10, 2026
10
Apr

FDA Recall: MAFA ratio of AneurysmFlow safety issue

April 10, 2026
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 4/10/2026 Class: II 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. Recall Number: Z-1805-2026 REASON: Potential safety issue involving the Mean Aneurysm Flow Amplitude...
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