BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1892-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1892-2019
    Event ID
    83056
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi America, Ltd., Power Systems Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2019
    Initiation Date
    April 15, 2019
    Classification Date
    June 27, 2019
    Termination Date
    April 24, 2020
    Address
    1840 Old Spanish Trl, N/A, Houston, TX, 77054-2002, United States

    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.

    Code Info

    2015B01, A01, A02

    Distribution

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

    Quantity

    3