Ingenia Elition S Magnetic Resonance — Class II medical device recall Z-2399-2023
Ongoing recall by Philips North America, reported 2023-08-16, distributed nationwide. During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock an
| Recall number | Z-2399-2023 |
|---|---|
| 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 | 601 total |
| UPC / GTIN / UDI-DI | 00884838088108, 00884838098329 |
| Serial numbers | 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 4601646015, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025, 46026, 46027, 46029, 46030, 46031 and 105 more |
Product
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Reason for recall
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock 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-2399-2023. 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.