Device recall
Z-1883-2008: GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1883-2008 |
|---|---|
| Recall event | 49487 |
| Product | GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. The intended use of this product is to generate tomographic images of human anatomy. |
| Product code | KPR |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| 510(k) numbers | K051967 |
| 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