GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile… — Class II medical device recall Z-0725-2014
Terminated recall by GE Healthcare, LLC, reported 2014-01-22, distributed nationwide. There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Dig
| Recall number | Z-0725-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-11-07 |
| Classified | 2014-01-11 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2014-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BH, BR, CA, CL, CN, CO, DE, DK, ES, FI, FR, GB, GR, HU, IE, IN, IQ, IT, JO, JP, KR, KW, MX, MY, NG, NO, NZ, PL, RO, SA, SE, SG, TH, TR, TT, ZA |
| Quantity | 1,027 |
| Reason classes | software |
| Serial numbers | 00000002796EN1, 00000002797EN9, 00000002798EN7, 00000002799EN5, 00000002800EN1, 00000002801EN9, 00000102726WK9, 00000102789WK3, 00000102937WK7, 00000130778WK3, 00000UA45526-8, 00001027058WK5, 00001027061WK9, 00001027146WK8, 00001027149WK2, 00001027150WK0, 00001027151WK8, 00001027153WK4, 00001027154WK2, 00001027167WK4, 00001027168WK2, 00001027169WK0, 00001027175WK7, 00001027193WK0, 00001027194WK8 and 475 more |
| Model numbers | 5421698, 5555000-5, 5555000-6 |
Product
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Reason for recall
There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams w
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-0725-2014. 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.