GE Healthcare — Class II medical device recall Z-1480-2014
Terminated recall by GE Healthcare, LLC, reported 2014-04-30, distributed nationwide. Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradie
| Recall number | Z-1480-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-04-02 |
| Classified | 2014-04-21 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2015-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IT, JP, KR, KW, KY, LB, MA, MX, NL, NO, NZ, OM, PL, QA, RO, RS, RU, SA, SE, SG, TH, TN, TR, TW, UY, VE, ZA |
| Reason classes | device malfunction |
Product
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
Reason for recall
Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localize
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-1480-2014. 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.