BEUDAMED
    FDA Recall Terminated

    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

    Recall: Z-0527-04 · Initiated January 16, 2004

    Recall

    Recall Number
    Z-0527-04
    Event Number
    28161
    Firm
    GVI Technology Partners
    FEI Number
    3003917438
    Product Code
    IYX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 16, 2004
    Posted
    February 10, 2004
    Terminated
    April 12, 2012
    Address
    1470 Enterprise Pkwy, Twinsburg, OH, 44087-2242

    Description

    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

    Reason

    Due to limitations in the operating software, the acquired scan may not be processed properly.

    Action

    The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit.

    Distribution

    One Single customer.

    Quantity

    16 units