Z-1447-2008

Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an...

Name: Z-1447-2008 Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an...
Creator: Given Imaging Inc
Published: 2007-12-13
License: https://open.fda.gov/license/

Given Imaging Ltd. / initiated 2007-12-13 / Terminated / root cause: manufacturing process

FDA source

Given Imaging Inc began a recall of Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule... on 2007-12-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1447-2008
Status: Terminated
Initiated: 2007-12-13
Posted: 2008-08-20
Terminated: 2010-11-15
Recalling firm: Given Imaging Ltd.
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. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.
Product code: NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 1392 units
Distribution: Worldwide Distribution --- US including Puerto Rico and country of Canada
Product codes and lots: GMB-0253-01-GLR Card-Proposed Diagnostic Algorithm for Suspected Crohn's Disease.

Product code NEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)