Device recall
Z-1942-2013: GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1942-2013 |
|---|---|
| Recall event | 64992 |
| Product | GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column… |
| Product code | IZL |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2014 |
| 510(k) numbers | K103476 |
| 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