BEUDAMED
    FDA Enforcement Class II Terminated

    RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

    Recall: Z-2087-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2087-2015
    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 GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

    Reason

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

    Code Info

    21839093 21840093 21841093 21845093 21849093 21850093 21851093 21855093 21856093 21861093 23641024 24340064 24343064 24347064 24358064 24359064 24368064 24728094 24736094 25103104 25104104 25127104 25129104

    Distribution

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

    Quantity

    19 units