BEUDAMED
    FDA Recall Terminated

    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

    Recall: Z-1585-2016 · Initiated March 31, 2016

    Recall

    Recall Number
    Z-1585-2016
    Event Number
    73745
    Firm
    Shimadzu Medical Systems
    FEI Number
    1000125362
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 31, 2016
    Posted
    April 28, 2016
    Terminated
    January 2, 2017
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328

    Description

    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

    Reason

    Report of unintentional movement of table to reverse tilting.

    Action

    Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers on April 8, 2016. Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray Diagnostic Table. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contacted Shimadzu National Technical Support at (800) 228-1429. Shimadzu will send out an updated customer notification letter to inform customers that the liquid penetration may cause an electrical short circuit, causing the table to unintentionally tilt in reverse. If this unintentional reverse tilting occurs, there is a potential risk of injury to the patient and/or the user. For questions regarding this recall call 310-217-8855, ext 139.

    Distribution

    Nationwide Distribution

    Quantity

    185 units