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U.S. Department of Health and Human Services

Class 2 Device Recall Given Diagnostic System with PillCam SB Capsule

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 Class 2 Device Recall Given Diagnostic System with PillCam SB Capsulesee related information
Date Initiated by FirmDecember 13, 2007
Date PostedAugust 20, 2008
Recall Status1 Terminated 3 on November 15, 2010
Recall NumberZ-1447-2008
Recall Event ID 46388
Product Classification Gastrointestinal wireless capsule - Product Code NEZ
ProductGiven 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.
Code Information GMB-0253-01-GLR Card-Proposed Diagnostic Algorithm for Suspected Crohn's Disease.
FEI Number 3003141635
Recalling Firm/
Manufacturer		 Given Imaging Inc
3950 Shackleford Rd
Duluth GA 30096-1858
For Additional Information ContactTim Thomas
770-662-0870
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionConsignees 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 Commerce1392 units
DistributionWorldwide Distribution --- US including Puerto Rico and country of Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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