Device recall
Z-1973-2015: GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1973-2015 |
|---|---|
| Recall event | 71508 |
| Product | GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. |
| Product code | IZI |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2015 |
| 510(k) numbers | K122457 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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