Anerysmflow_interventional Tool [mdr]
AnerysmFlow Interventional Tool Recall Summary Philips Medical Systems Nederland BV is recalling the AnerysmFlow Interventional Tool in New Zealand due to a software upgrade requirement. The device is used in hospitals, pharmacies, and laboratories for aneurysm intervention procedures. This is classified as a Class I recall, the most serious type.
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- AnerysmFlow_Interventional Tool [MDR]. [Device]. Model: Philips AneurysmFlow
- Reason
- The manufacturer has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment. The Instructions for Use (IFU) of AneurysmFlow state that the MAFA ratio should not be used for making clinical decisions (Section 9.2 Measuring Flow). In addition, when hovering over the MAFA ratio header within the software interface, an on-screen message states that the MAFA ratio is not to be used for clinical decision making. Despite the existing cautions, the displayed MAFA ratio may still be considered during...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-04-16
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a9810c54-3331-4971-8fd4-bc8d63153cc7