GE Healthcare — Class II medical device recall Z-0954-2015
Terminated recall by GE Healthcare, reported 2015-01-21, distributed in DC, GU. GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel ca
| Recall number | Z-0954-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2014-12-08 |
| Classified | 2015-01-12 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2016-02-03 |
| Distributed | DC, GU |
| Countries outside the US | AT, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, EC, EG, ES, FI, FR, GB, GR, HK, HN, HU, ID, IE, IL, IT, JP, KR, KW, LT, LV, MX, MY, NL, NO, NZ, PH, PK, PL, PT, SA, SE, TH, TW, UA, UY, VE, VN, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00000000000000, 00082407040209, 00082407040216, 00082407040377, 00082407050055, 00082407070077, 00082407090136, 00082407150021, 00082407160198, 00082407190034, 00082407290024 |
| Model numbers | 600-0301 |
Product
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.
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-0954-2015. 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.