OEC Elite: The OEC Elite mobile C-arm is intended to provide… — Class II medical device recall Z-1819-2025
Ongoing recall by GE Medical Systems, LLC, reported 2025-06-18. OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
| Recall number | Z-1819-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-03-21 |
| Classified | 2025-06-09 |
| Reported by FDA | 2025-06-18 |
| UPC / GTIN / UDI-DI | 00001234567895, 00195278096944 |
| Serial numbers | FAHXTX00002, FAHXTX00005, FAHXTX00014, FAHXTX00018, FAHXTX00019, FAHXTX00020, FAHXTX00024, FAHXTX00028, FAHXTX00034, FAHXTX00037, FAHXTX00043, FAHXTX00052, FAHXTX00063, FAHXTX00066, FAHXTX00068, FAHXTX00070, FAHXTX00075, FAHXTX00078, FAHXTX00079, FAHXTX00080, FAHXTX00081, FAHXTX00083, FAHXTX00092, FAHXTX00093, FAHXTX00097 and 475 more |
Product
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Reason for recall
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
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-1819-2025. 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.