Achieva 1 — Class II medical device recall Z-0390-2024
Ongoing recall by Philips North America Llc, reported 2023-11-29, distributed nationwide. Potential component failure in the Gradient Coil could product smoke and/or fire.
| Recall number | Z-0390-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2023-10-23 |
| Classified | 2023-11-21 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, LB, LU, MT, MX, MY, NL, NO, NP, NZ, PA, PE, PK, PL, PT, RO, RS, SA, SE, SG, SK, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 68 units |
| UPC / GTIN / UDI-DI | 00884838009806, 00884838068469 |
| Serial numbers | 10189, 10194, 10219, 10821, 18505, 18737, 39001, 39027, 39028, 39030, 39032, 39039, 39053, 39059, 39061, 39062, 39064, 39065, 39066, 39067, 39072, 39073, 39074, 39075, 39078 and 43 more |
Product
Achieva 1.5T Conversion
Reason for recall
Potential component failure in the Gradient Coil could product smoke and/or fire.
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-0390-2024. 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.