GE Healthcare Optima XR200amx — Class II medical device recall Z-0811-2025
Ongoing recall by GE Medical Systems, LLC, reported 2025-01-15. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacem
| Recall number | Z-0811-2025 |
|---|---|
| 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 | 2024-11-25 |
| Classified | 2025-01-07 |
| Reported by FDA | 2025-01-15 |
| Quantity | 53 units |
| UPC / GTIN / UDI-DI | 00840682115278 |
| Serial numbers | 10523MOB01, 1553XR0081, 201418DIG1, 210297NC200M1, 229276M200, 240566P1, 260665XR220, 316858AMX200P1, 316962240P1, 361572XR220C, 401OPTI3, 405717P200, 408259AP8, 410368WP1, 443643WP1, 478757OPT, 503251XR200, 512SDERLM1, 512SDMCP1, 518243OPT2, 518583OPT1, 603356OPTIMA, 609267OPT, 609267OPT3, 661949DP1 and 28 more |
Product
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Reason for recall
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
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-0811-2025. 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.