BEUDAMED
    FDA Recall Terminated

    Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344

    Recall: Z-0055-05 · Initiated September 30, 2004

    Recall

    Recall Number
    Z-0055-05
    Event Number
    30206
    Firm
    Fujifilm Medical System USA, Inc.
    FEI Number
    1000513161
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 30, 2004
    Posted
    October 28, 2004
    Terminated
    December 22, 2004
    Address
    419 West Ave, Stamford, CT, 06902-6300

    Description

    Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344

    Reason

    Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use.

    Action

    Fuji are notifying users through Fuji service representatives who are hand delivering the notfication letter dated 9/30/04 and installing the mandatory hardware upgrade.

    Distribution

    CO, CT, NY, MD, MI, MN, NV, UT

    Quantity

    16