Recall Z-1447-2008 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Given Imaging Inc
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. The device captures images of the small bowel with a wireless camera contained in a capsule. This dev
| Date | Aug 20, 2008 (initiated Dec 13, 2007) |
| Status | Terminated |
| Reason | The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly. |
| Root cause | Employee error |
| Action | Consignees were notified by letter on 12/13/2007. The letter contains a diagram illustrating the error on the incorrect card and a diagram illustrating the corrected card. Consignees were instructed to discard the incorrect card if they still have it and to complete a response form and return it via fax to Given Imaging. |
| Quantity | 1392 units |
| Distribution | Worldwide Distribution --- US including Puerto Rico and country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.