GE Healthcare — Class II medical device recall Z-0768-2016
Terminated recall by GE Medical Systems, LLC, reported 2016-02-17, distributed in GU, PR, WA. Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm
| Recall number | Z-0768-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2015-12-23 |
| Classified | 2016-02-09 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-09-07 |
| Distributed | GU, PR, WA |
| Countries outside the US | AE, AF, AT, AU, BE, BG, BH, BM, BO, BR, BS, CA, CL, CN, CO, CR, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HU, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LB, MX, MY, NG, NL, NO, NZ, PA, PH, PK, PL, PT, PY, RO, SA, SE, SG, TH, TR, TT, TW, UY, VE, VN, ZA |
| Quantity | 2,389 |
| UPC / GTIN / UDI-DI | 00000001033991 |
Product
GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Reason for recall
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
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-0768-2016. 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.