Device recall
Z-2387-2018: Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
FDA device recall · Class II · GE Medical Systems, SCS
Key facts
| Recall number (Z-number) | Z-2387-2018 |
|---|---|
| Recall event | 80177 |
| Product | Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems |
| Product code | OWB |
| Recalling firm | GE Medical Systems, SCS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 2021 |
| 510(k) numbers | K111209, K122457 |
| FEI number | 1000284313 |
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