Device recall
Z-2870-2018: GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The…
FDA device recall · Class II · GE Healthcare Japan Corporation
Key facts
| Recall number (Z-number) | Z-2870-2018 |
|---|---|
| Recall event | 80563 |
| Product | GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT… |
| Product code | JAK |
| Recalling firm | GE Healthcare Japan Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| 510(k) numbers | K131576 |
| FEI number | 3002808529 |
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