Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers
FDA device recall Z-1748-2011 · posted 2011-03-23 · Terminated
Recall details
- Recalling firm
- Given Imaging Ltd.
- Reason for recall
- The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NEZ
- Quantity affected
- 389
- Distribution
- U.S. Nationwide, Canada, Germany Israel and Australia.
- Date initiated
- 2011-03-08
- Date posted
- 2011-03-23
- Date terminated
- 2011-12-02
- Location
- Norcross, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE (K101200) | Given Imaging , Ltd. | 2010-09-30 |