Device recall
Z-1118-2009: Definium 5000 X-ray System, model number 5220493 and 5220393-2
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1118-2009 |
|---|---|
| Recall event | 51490 |
| Product | Definium 5000 X-ray System, model number 5220493 and 5220393-2 |
| Product code | KPR |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2012 |
| 510(k) numbers | K063283 |
| FEI number | 2126677 |
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