BEUDAMED
    FDA Recall Terminated

    Drystar Mammo. Display of Mammographic images.

    Recall: Z-0916-2012 · Initiated March 2, 2010

    Recall

    Recall Number
    Z-0916-2012
    Event Number
    60762
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 2, 2010
    Terminated
    February 14, 2012
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Drystar Mammo. Display of Mammographic images.

    Reason

    Labeling problem

    Action

    The firm, AGFA Corporation spoke to the customer directly via telephone concerning the mislabeled affected products. The firm also contacted the customer via e-mail on April 13, 2011 explaining the outcome of the customer complaint. Replacement product was sent to the customer.

    Distribution

    Product distributed in Florida.

    Quantity

    2 boxes