GE Healthcare — Class II medical device recall Z-2339-2015
Terminated recall by GE Healthcare, reported 2015-08-12, distributed nationwide. A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable termi
| Recall number | Z-2339-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-07-10 |
| Classified | 2015-08-05 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2015-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BR, CA, CN, EG, FI, FR, GB, HU, ID, IN, IT, JP, KR, MX, NZ, TW, ZA |
| UPC / GTIN / UDI-DI | 00082427010077 |
Product
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
Reason for recall
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
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-2339-2015. 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.