Device recall
Z-1248-2015: GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1248-2015 |
|---|---|
| Recall event | 70514 |
| Product | GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications. |
| Product code | KPR |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2015 |
| 510(k) numbers | K993090 |
| 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