Device recall
Z-1748-2011: Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB…
FDA device recall · Class II · Given Imaging Ltd.
Key facts
| Recall number (Z-number) | Z-1748-2011 |
|---|---|
| Recall event | 58137 |
| Product | Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak). |
| Product code | NEZ |
| Recalling firm | Given Imaging Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2011 |
| 510(k) numbers | K101200 |
| FEI number | 3003141635 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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