BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1574-2015 · Initiated April 17, 2015

    Recall

    Recall Number
    Z-1574-2015
    Event Number
    70638
    Firm
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan
    FEI Number
    3006942329
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    April 17, 2015
    Posted
    May 1, 2015
    Terminated
    April 11, 2017

    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.

    Action

    MITSUBISHI HEAVY INDUSTRIES, LTD. has issued a Safety Alert for the MHI-TM2000 Linear Accelerator System dated April 10, 2015, due to a software issue. Customers were advised not to deliver therapeutic X-ray if popup warning message show is displayed during treatment. Instructions were provided if therapeutic radiation is delivered during popup warning. Customers with questions should contact the Customer Service Representative by calling 1-800-597-5911, Monday through Friday or email: [email protected]. **CAPA** Correction software for this issue has a tentative availability date of June 2015. Estimated software update completion date would be end of October 2015.

    Distribution

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

    Quantity

    11 units total