BEUDAMED
    FDA Recall Terminated

    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.

    Recall: Z-0232-2018 · Initiated June 15, 2017

    Recall

    Recall Number
    Z-0232-2018
    Event Number
    78644
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 15, 2017
    Terminated
    May 9, 2018
    Address
    419 West Ave, Stamford, CT, 06902-6343

    Description

    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.

    Reason

    A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

    Action

    FUJIFILM Medical Systems U.S. A. Inc. (FMSU) sent "Urgent: Medial Device Correction" recall notification letter dated June 21, 2017 to all Customers. Customers were notified of the recall, potential issue, potential hazard, description of the issue, the actions planned to correct the issue, the actions to be taken by the customer and contact information. A Customer Feedback Form was provided accompanying the letter. FMSU service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. As FMSUs planned field correction at the affected sites, FMSU will install the additional 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. For further questions, please call (203) 324-2000.

    Distribution

    US Distribution.

    Quantity

    3