BEUDAMED
    FDA Recall Terminated

    DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.

    Recall: Z-0464-2011 · Initiated October 8, 2010

    Recall

    Recall Number
    Z-0464-2011
    Event Number
    57109
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 8, 2010
    Posted
    November 26, 2010
    Terminated
    December 30, 2010
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.

    Reason

    Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.

    Action

    Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.

    Distribution

    Nationside Distribution: to NJ.

    Quantity

    One unit