Device recall
Z-2038-2012: OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm…
FDA device recall · Class I · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2038-2012 |
|---|---|
| Recall event | 51222 |
| Product | OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system… |
| Product code | JAA |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 19, 2013 |
| 510(k) numbers | K021049, K022069, K024012 |
| FEI number | 1720753 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database