BEUDAMED
    FDA Recall Terminated

    DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.

    Recall: Z-1799-2010 · Initiated April 22, 2010

    Recall

    Recall Number
    Z-1799-2010
    Event Number
    55658
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2010
    Posted
    June 11, 2010
    Terminated
    February 1, 2011
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.

    Reason

    The RF tags on the white protection sheets of the media stacks were incorrect.

    Action

    AGFA Healthcare issued an "Urgent Safety Notice" dated April 22, 2010 requesting a check of warehouse inventory and a request for a sub-recall, if necessary. All affected product should be returned to the firm for replacement. For further information, contact AGFA Healthcare at 1-877-777-2432.

    Distribution

    Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.

    Quantity

    180 boxes