Device recall
Z-0401-2016: GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0401-2016 |
|---|---|
| Recall event | 72617 |
| Product | GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from… |
| Product code | JAK |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2016 |
| 510(k) numbers | K133705 |
| 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