Philips Zenition 70 — Class II medical device recall Z-0353-2025
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-11-20, distributed nationwide. Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
| Recall number | Z-0353-2025 |
|---|---|
| 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 | 2024-10-07 |
| Classified | 2024-11-12 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LB, LT, MA, MT, MX, MY, NG, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RS, SA, SE, SG, SK, SV, TH, TR, TT, TW, UA, VN, ZA |
| UPC / GTIN / UDI-DI | 00884838091528 |
| Serial numbers | 1001, 1009, 101, 1010, 1011, 1012, 1013, 1014, 1015, 1019, 102, 1024, 103, 1033, 1034, 1035, 1036, 1037, 1038, 1039, 104, 1043, 1044, 1045, 1046 and 475 more |
| Model numbers | 718133 |
Product
Philips Zenition 70, Model Number: 718133
Reason for recall
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a 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-0353-2025. 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.