BEUDAMED
    FDA Recall Terminated

    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.

    Recall: Z-0251-2016 · Initiated September 30, 2015

    Recall

    Recall Number
    Z-0251-2016
    Event Number
    72376
    Firm
    Shimadzu Medical Systems
    FEI Number
    1000125362
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 30, 2015
    Terminated
    September 12, 2016
    Address
    20101 S Vermont Ave, Torrance, CA, 90502-1328

    Description

    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.

    Reason

    The C-arm may interfere with the table top under certain circumstances.

    Action

    An Urgent Voluntary Medical Device Recall notice was sent on 9/30/2015 to all the customers who purchased the Shimadzu C-arm Table (Catalog No. IVS-110). The notification informs the customers of the description of the issue, the actions to be taken by Shimadzu to correct the issue, and the actions to be taken by the customers. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

    Distribution

    Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.

    Quantity

    26 units total (4 units in US)