BEUDAMED
    FDA Enforcement Class II Terminated

    RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

    Recall: Z-2088-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2088-2015
    Event ID
    71628
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Eizo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    July 7, 2015
    Classification Date
    July 16, 2015
    Termination Date
    November 30, 2016
    Address
    153, Shimokashiwano, Hakusanshi, N/A, N/A, Japan

    Description

    RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

    Reason

    EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.

    Code Info

    20326034, 20618064, 20671064

    Distribution

    Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.

    Quantity

    3 units