fda_recall · device_recall · high
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic…
- Event date
- 2026-04-22 00:00:00Z
- Observed
- 2026-07-09 22:53:03Z
- Source ID
- Z-1805-2026
- Payload hash
- f7ce6fd6b87f1cd87b64786f…
Summary
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 bein… Status: Ongoing.
Informational only. Not legal, financial, or medical advice.