Device recall
Z-2871-2018: GE Healthcare Optima CT660. Sold under the following product names: BEIJING…
FDA device recall · Class II · GE Healthcare Japan Corporation
Key facts
| Recall number (Z-number) | Z-2871-2018 |
|---|---|
| Recall event | 80563 |
| Product | GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 660 MID HN P20, CT OPTIMA 660… |
| Product code | JAK |
| Recalling firm | GE Healthcare Japan Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| 510(k) numbers | K110227 |
| 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