Device recall
Z-1134-2008: GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1134-2008 |
|---|---|
| Recall event | 48144 |
| Product | GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with… |
| Product code | KPR |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2008 |
| 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