Philips Ingenia Elition X MR System — Class II medical device recall Z-0460-2023
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-0460-2023 |
|---|---|
| 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 | 00884838088115, 00884838098336, 00884838104129, 00884838108608 |
| Serial numbers | 45002, 45010, 45011, 45024, 45026, 45027, 45032, 45035, 45051, 45053, 45054, 45055, 45060, 45068, 45075, 45078, 45082, 45086, 45087, 45089, 45092, 45099, 45100, 45108, 45112 and 48 more |
| Model numbers | 781358, 782107, 782119, 782136 |
Product
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
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-0460-2023. 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.