OEC 8800 Flexiview designed to provide fluoroscopic and spot-film… — Class II medical device recall Z-2027-2012
Terminated recall by GE OEC Medical Systems, Inc, reported 2012-07-25. Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues th
| Recall number | Z-2027-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2007-11-19 |
| Classified | 2012-07-18 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-01-28 |
| Quantity | 1,349 units |
| Serial numbers | 8800 |
| Model numbers | 8800 |
Product
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Reason for recall
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
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-2027-2012. 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.