Ingenia Elition S-Magnetic Resonance Medical Electrical Systems… — Class II medical device recall Z-2347-2021
Terminated recall by Philips North America Llc, reported 2021-09-01, distributed nationwide. Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in relea
| Recall number | Z-2347-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-07-30 |
| Classified | 2021-08-25 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2023-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CL, CN, CZ, DE, DK, ES, FR, GB, ID, IN, IT, JP, KR, LB, MX, NL, RO, SA, TR, UA |
| Quantity | 7 units |
| UPC / GTIN / UDI-DI | 00884838088108 |
| Model numbers | 781357 |
Product
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS)
Reason for recall
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
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-2347-2021. 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.