Recall Z-1748-2011 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Given Imaging Ltd.
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).
| Date | Mar 23, 2011 (initiated Mar 8, 2011) |
| Status | Terminated |
| Reason | The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval. |
| Root cause | Device Design |
| Action | Given Imaging, Inc. consignees were notified via FedEx letter on/about 03/08/2011. They instructed to return all affected product. A Customer Response form with return instructions was included to be completed and returned to Given Imaging. |
| Quantity | 389 |
| Distribution | U.S. Nationwide, Canada, Germany Israel and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE Given Imaging , Ltd., Sep 30, 2010 |