Z-1748-2011

Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device...

Name: Z-1748-2011 Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device...
Creator: Given Imaging Ltd.
Published: 2011-03-08
License: https://open.fda.gov/license/

Given Imaging Ltd. / initiated 2011-03-08 / Terminated / root cause: design

FDA source

Given Imaging Ltd. began a recall of 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) on 2011-03-08. The reason FDA records is "The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1748-2011
Status: Terminated
Initiated: 2011-03-08
Posted: 2011-03-23
Terminated: 2011-12-02
Recalling firm: Given Imaging Ltd.
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 System, Imaging, Gastrointestinal, Wireless, Capsule
Reason for recall: The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
Root cause tag: design
FDA 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 in commerce: 389
Distribution: U.S. Nationwide, Canada, Germany Israel and Australia.
Product codes and lots: FGS# 0366, Lot number: 14081, 13688, 14097, 14144, 13783 and 13504, UPC: 7290101362050 and FGS# 0367, Lot number: 13438, 13690, 13781, 13806, 14082, 14095, 14099.14145, 14249, 14370, 14568, 14508 and 14787, UPC: 7290101362067.

Product code NEZ

K101200Class IIPillcam Express Video Capsules Delivery DeviceGiven Imaging , Ltd. / cleared 2010-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)