Ingenia 1 — Class II medical device recall Z-1865-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-07-02, distributed nationwide. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10
| Recall number | Z-1865-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-06-13 |
| Classified | 2014-06-24 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2016-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CH, CL, CN, DE, FR, GB, HK, ID, IE, IN, IT, JP, KR, MX, NO, NZ, PL, PT, QA, SE, TN, TR, TW, VE, VN, ZA |
| Quantity | 24 |
| Model numbers | 781396 |
Product
Ingenia 1.5T, magnetic resonance imaging system.
Reason for recall
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
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-1865-2014. 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.