BEUDAMED
    FDA Recall 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 · Initiated July 7, 2015

    Recall

    Recall Number
    Z-2088-2015
    Event Number
    71628
    Firm
    Eizo Corporation 153 Shimokashiwano Hakusanshi Japan
    FEI Number
    3000237660
    Product Code
    PGY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 7, 2015
    Posted
    July 16, 2015
    Terminated
    November 30, 2016

    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.

    Action

    EIZO sent An Urgent Field Safety Notice dated July 7, 2015, to all customers who purchased the RadiForce RX440, RX650, RX850 and GX540. The notice informs customers that the RadiForce monitors could display abornormally in 6-bit (64 gradations) instead of normal 8-bit (256 gradations) or 10-bit (1024 gradations) while connecting to particular graphics boards with DisplayPort. The notice provides the customers with the actions to be taken and contact information (1-800-800-5202, M-F, 8am-4pm, PST, [email protected], 5710 Warland Drive, Cypress, CA 90630).

    Distribution

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

    Quantity

    3 units