BEUDAMED
    FDA Recall Terminated

    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals

    Recall: Z-2655-2017 · Initiated May 23, 2017

    Recall

    Recall Number
    Z-2655-2017
    Event Number
    77351
    Firm
    Shimadzu Medical Systems Usa Com
    FEI Number
    1000125362
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 23, 2017
    Terminated
    October 1, 2019
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328

    Description

    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals

    Reason

    Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

    Action

    Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers. The firm will implement a voluntary recall/field corrective action to add protective parts preventing the x-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. Customers with questions were instructed to call 800-228-1429.

    Distribution

    Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan

    Quantity

    1673 units total