BEUDAMED
    FDA Enforcement Class II Ongoing

    RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

    Recall: Z-2293-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2293-2020
    Event ID
    85299
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Eizo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    June 17, 2020
    Initiation Date
    July 30, 2019
    Classification Date
    June 8, 2020
    Address
    Eizo ( Kabu ), N/A, Hakusan, N/A, N/A, Japan

    Description

    RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

    Reason

    Under certain conditions, a marble pattern infrequently appears on the monitor.

    Code Info

    RadiForce GX560 - 1.0003 or earlier

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Massachusetts, Michigan, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin. Distribution was also made to Puerto Rico. There was no government/military consignees. The countries of Canada, Australia, Austria, Belgium, Brazil, China, Czech Republic, Egypt, France, Germany Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Netherlands, Pakistan, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    96 monitors dist. to the U.S.