BEUDAMED
    FDA Enforcement Class II Terminated

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    Recall: Z-1574-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1574-2015
    Event ID
    70638
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2015
    Initiation Date
    April 17, 2015
    Classification Date
    May 1, 2015
    Termination Date
    April 11, 2017
    Address
    6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA, N/A, N/A, Japan

    Description

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    Reason

    The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.

    Code Info

    Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924

    Distribution

    Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.

    Quantity

    11 units total