Philips AneurysmFlow — Class II medical device recall Z-1805-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-04-22, distributed nationwide. Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional
| Recall number | Z-1805-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2026-03-19 |
| Classified | 2026-04-10 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CZ, DE, EE, EG, GR, HR, ID, IQ, IT, JP, KW, LK, LV, MA, NI, NZ, PL, PT, RO, RS, SA, SI, TR, UA, VN, ZA |
| Quantity | 1,033 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838054202, 00884838054219, 00884838054226, 00884838054240, 00884838059054, 00884838059061, 00884838059115, 00884838059122, 00884838085268, 00884838085367, 00884838099234, 00884838099258, 00884838099272, 00884838110571, 00884838116771, 00884838116801 |
| Model numbers | 001015 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1805-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.