BEUDAMED
    FDA Enforcement Class II Terminated

    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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-1931-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1931-2013
    Event ID
    65786
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2013
    Initiation Date
    June 21, 2013
    Classification Date
    August 8, 2013
    Termination Date
    March 23, 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 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.

    Code Info

    Serial Numbers #s 201902 and 203901

    Distribution

    Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.

    Quantity

    14 (2 in US)