Device recall
Z-1447-2008: Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule…
FDA device recall · Class II · Given Imaging Inc
Key facts
| Recall number (Z-number) | Z-1447-2008 |
|---|---|
| Recall event | 46388 |
| Product | Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel… |
| Product code | NEZ |
| Recalling firm | Given Imaging Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2010 |
| 510(k) numbers | K010312 |
| 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