BEUDAMED
    FDA Enforcement Class II Terminated

    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    Recall: Z-1585-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1585-2018
    Event ID
    79439
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Ltd., Medical System Operations Group
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 9, 2018
    Initiation Date
    December 8, 2017
    Classification Date
    May 1, 2018
    Termination Date
    April 11, 2019
    Address
    2-1, Shintoyofuta, Kashiwa, N/A, N/A, Japan

    Description

    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    Reason

    Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.

    Code Info

    Serial Number: 203919

    Distribution

    US Distribution in the state of NY.

    Quantity

    1