Device recall
Z-1788-2012: GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview, Waukesha…
FDA device recall · Class II · General Electric Med Systems LLC
Key facts
| Recall number (Z-number) | Z-1788-2012 |
|---|---|
| Recall event | 37654 |
| Product | GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic… |
| Product code | MQB |
| Recalling firm | General Electric Med Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 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