Ingenia Elition S Model Numbers — Class II medical device recall Z-2210-2025
Ongoing recall by Philips North America, reported 2025-08-06, distributed nationwide. The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source
| Recall number | Z-2210-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2025-06-30 |
| Classified | 2025-07-30 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BO, BR, BZ, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TT, TW, UA, VE, VN, ZA |
| Quantity | 242 units |
| UPC / GTIN / UDI-DI | 00884838088108, 00884838098329, 00884838108615 |
| Serial numbers | 26001, 26002, 26003, 26004, 26005, 26006, 26007, 26008, 26010, 26011, 26012, 26013, 26014, 26015, 26016, 26017, 26018, 26020, 26021, 26022, 26023, 26024, 26026, 26027, 26029 and 217 more |
| Model numbers | 00884838088108, 00884838098329, 00884838108615, 781357, 782106, 782137, 782150 |
Product
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Reason for recall
The potential for component failures in the Gradient Coil of the affected MR systems 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-2210-2025. 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.