Philips Ingenia Elition S MR System — Class II medical device recall Z-0459-2023
Ongoing recall by Philips North America Llc, reported 2022-12-14, distributed nationwide. Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
| Recall number | Z-0459-2023 |
|---|---|
| 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 | 2022-11-22 |
| Classified | 2022-12-08 |
| Reported by FDA | 2022-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 566 total |
| UPC / GTIN / UDI-DI | 00884838088108, 00884838098329, 00884838108615 |
| Serial numbers | 46002, 46014, 46025, 46065, 46071, 46077, 46088, 46097, 46109, 46224, 46225, 46265, 46269, 46311 |
| Model numbers | 781357, 782106, 782137 |
Product
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Reason for recall
Gradient Coil may act as a heat source with a potential to produce 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-0459-2023. 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.