BEUDAMED
    FDA Enforcement Class II Terminated

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    Recall: Z-0821-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0821-2015
    Event ID
    69825
    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
    December 24, 2014
    Initiation Date
    December 2, 2014
    Classification Date
    December 17, 2014
    Termination Date
    June 26, 2017
    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, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    Reason

    Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port

    Code Info

    Serial Numbers: 201902, 203901, 203919, and 203924 (US only)

    Distribution

    US Distribution to the states of NY, FL, TX and OH.

    Quantity

    Domestic: 4 units