BEUDAMED
    FDA Recall Terminated

    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

    Recall: Z-1892-2019 · Initiated April 15, 2019

    Recall

    Recall Number
    Z-1892-2019
    Event Number
    83056
    Firm
    Hitachi America, Ltd., Power Systems Division
    FEI Number
    3003993895
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 15, 2019
    Terminated
    April 24, 2020
    Address
    1840 Old Spanish Trl, Houston, TX, 77054-2002

    Description

    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

    Reason

    There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.

    Action

    The firm informed affected user sites of the recall beginning on April 15, 2019, via an Engineering Document. The firm distributed updated Urgent Medical Device Recall letters in June 2019. The firm stated that the PIAS software would be replaced with the corrected version. Until the software was corrected, users were asked to take the following interim countermeasures: -Limit the number of treatment planning CT slices to odd numbers only. - Create treatment plan only in Head First condition for new patients. - Use the beam limiting device in full open in the lateral direction (same as before). Customers were asked to complete and return the customer response form to the firm. The firm stated that the software correction will be implemented from June 17 - 29, 2019.

    Distribution

    Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.

    Quantity

    3