Device recall
Z-2125-2012: OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide…
FDA device recall · Class II · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2125-2012 |
|---|---|
| Recall event | 62449 |
| Product | OEC 9800 Plus Digital; MDL number A349855. Product Usage: 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… |
| Product code | IZL |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2012 |
| 510(k) numbers | K021049 |
| 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