BEUDAMED
    FDA Enforcement Class II Terminated

    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. 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-2653-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2653-2014
    Event ID
    68909
    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
    September 24, 2014
    Initiation Date
    July 5, 2014
    Classification Date
    September 16, 2014
    Termination Date
    April 1, 2015
    Address
    6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA, N/A, N/A, Japan

    Description

    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. 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

    Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment

    Code Info

    Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919

    Distribution

    Distributed in the states of NY, FL, and TX.

    Quantity

    3 units in use in the US