Azurion 3 with a Certeray generator -To perform image guidance in… — Class II medical device recall Z-1176-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-02-28, distributed nationwide. Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR
| Recall number | Z-1176-2024 |
|---|---|
| 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 | 2024-02-06 |
| Classified | 2024-02-22 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BR, CH, CN, CO, CZ, DE, DZ, EC, ES, FR, GB, HR, HU, ID, IL, IN, IQ, IT, JP, KR, KW, LT, MA, MY, NL, NO, OM, PA, PL, PT, QA, RO, SA, SE, TN, TR, TW, UA |
| Quantity | 14 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838099203, 00884838099210, 00884838099258, 00884838103276 |
| Model numbers | 722221, 722222, 722280 |
Product
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Reason for recall
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
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-1176-2024. 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.