BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1447-2008 · Initiated December 13, 2007

    Recall

    Recall Number
    Z-1447-2008
    Event Number
    46388
    Firm
    Given Imaging Inc
    FEI Number
    3003141635
    Product Code
    NEZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 13, 2007
    Posted
    August 20, 2008
    Terminated
    November 15, 2010
    Address
    3950 Shackleford Rd, Duluth, GA, 30096-1858

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Worldwide Distribution --- US including Puerto Rico and country of Canada

    Quantity

    1392 units