Drug recall
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic…
FDA recall event 62404 · Class II · GE OEC Medical Systems, Inc
Key facts
| Event ID | 62404 |
|---|---|
| Recall numbers | Z-2025-2012, Z-2026-2012, Z-2027-2012 |
| Recalling firm | GE OEC Medical Systems, Inc |
| Product type | Devices |
| Products | 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…, OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and…, OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 19, 2007 |
| Report date | Jul 25, 2012 |
| Termination date | Jan 28, 2013 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 1720753 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: