Device recall
Z-0528-2010: GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0528-2010 |
|---|---|
| Recall event | 52010 |
| Product | GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic Images of human anatomy.The device is not intended for mammographic applications. |
| Product code | KPR |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 24, 2012 |
| 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