BEUDAMED
    FDA Recall Terminated

    CR DX-S, Image Intensified Fluoroscopic X-ray system.

    Recall: Z-0031-2007 · Initiated June 28, 2006

    Recall

    Recall Number
    Z-0031-2007
    Event Number
    35994
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 28, 2006
    Posted
    October 12, 2006
    Terminated
    May 10, 2007
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    CR DX-S, Image Intensified Fluoroscopic X-ray system.

    Reason

    Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.

    Action

    Consignees were notified by letter on/about 06/28/2006.

    Distribution

    CA, DC, FL, MN, MI, MS, OR.

    Quantity

    11 units