Device recall
Z-1705-2008: OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC…
FDA device recall · Class II · OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-1705-2008 |
|---|---|
| Recall event | 47774 |
| Product | OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT. |
| Product code | JAA |
| Recalling firm | OEC Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2011 |
| 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