BEUDAMED
    FDA Recall Open, Classified

    RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

    Recall: Z-2294-2020 · Initiated July 30, 2019

    Recall

    Recall Number
    Z-2294-2020
    Event Number
    85299
    Firm
    Eizo Corporation Eizo Kabu Hakusan Japan
    FEI Number
    3000237660
    Product Code
    PGY
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 30, 2019

    Description

    RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

    Reason

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

    Action

    EIZO Japan announced the recall on their website on 7/30/2019. EIZO U.S. began contacting their consignees via email and phone (one as early as 8/7/2019, some on 10/18/2019, but the majority on 11/26/2019) and began updating consignee monitors with the firmware. The notification requested the consignee contact EIZO U.S. for assistance with the firmware update.

    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

    1,466 monitors dist. to the U.S.