BEUDAMED
    FDA Recall Terminated

    BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.

    Recall: Z-0193-2007 · Initiated August 1, 2006

    Recall

    Recall Number
    Z-0193-2007
    Event Number
    36381
    Firm
    Trionix Research Laboratory Inc
    FEI Number
    1527587
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2006
    Posted
    November 16, 2006
    Terminated
    October 29, 2008
    Address
    8037 Bavaria Rd, Twinsburg, OH, 44087-2261

    Description

    BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System.

    Reason

    The ball screw on the unit which supports the detector head (which weighs approximately 800 lbs.) could snap resulting in the detector head dropping on the patient.

    Action

    The recalling firm modified one of the devices in 2002. The remaining device users were telephoned on/about 11/02/2006. To date the recalling firm has not taken any corrective action regarding devices with serial numbers B-102, B-103, B-104 or B-106 thru B-184.

    Distribution

    Worldwide, including USA, Australia, Egypt, UK, Belgium.

    Quantity

    76 devices