Ingenia Elition S Magnetic Resonance — Class II medical device recall Z-2396-2023
Ongoing recall by Philips North America, reported 2023-08-16, distributed nationwide. The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detec
| Recall number | Z-2396-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-06-12 |
| Classified | 2023-08-10 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 640 total |
| UPC / GTIN / UDI-DI | 00884838088108, 00884838098329 |
| Serial numbers | 26001, 26003, 26006, 26010, 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 46015, 46016, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025 and 117 more |
Product
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Reason for recall
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
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-2396-2023. 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.