Optima XR200amx — Class II medical device recall Z-2726-2026
Ongoing recall by GE Medical Systems, LLC, reported 2026-07-22, distributed nationwide. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacem
| Recall number | Z-2726-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2026-06-05 |
| Classified | 2026-07-13 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, ES, GB, KR, MX, SA |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 00840682115278 |
Product
Optima XR200amx, Mobile Digital-Ready Radiographic System
Reason for recall
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
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-2726-2026. 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.