BEUDAMED
    FDA Recall Terminated

    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System

    Recall: Z-2188-2016 · Initiated February 24, 2016

    Recall

    Recall Number
    Z-2188-2016
    Event Number
    74473
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    February 24, 2016
    Posted
    July 18, 2016
    Terminated
    April 25, 2017
    Address
    2441 Michelle Dr PO Box 2068, Tustin, CA, 92780-7047

    Description

    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System

    Reason

    During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.

    Action

    Toshiba Medical Systems (TAMS) planned action to bring product into Compliance: 1.TAMS will install the software and perform testing to ensure the software update was effective. 2. The customer notification letter which includes a statement that TAMS will, without charge, remedy the defect or bring the product into compliance. . If you have any questions regarding this, please feel free to contact your local Toshiba representative at (800) 521-1968.

    Distribution

    US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.

    Quantity

    23