Events

Recall of Device Recall VERO Linear Accelerator System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69825
  • Event Risk Class
    Class 2
  • Event Number
    Z-0821-2015
  • Event Initiated Date
    2014-12-02
  • Event Date Posted
    2014-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131960
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • 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.
  • Action
    Mitsubishi sent a Field Safety Notice dated November 14, 2014, that was e-mailed to US end users on December 2, 2014, which provided actions to be taken by the end users. If users need any further information or support concerning this issue, they may contact MHI's Customer Service Representative, Brainlab AG in Germany, contact person: Franz Gum, Tel: +49-89-99-1568-0, Fax: +49-89-99-1568-33, E-mail: Franz.Gum@brainlab.com. If any other abnormality is detected, stop operation and contact MHI's Customer Service representative immediately. --- An Updated Field Safety Notice (dated December 4, 2014,) was sent to end users to correct some terms used in the initial notification.

Device

Device Recall VERO Linear Accelerator System
  • Model / Serial
    Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of NY, FL, TX and OH.
  • Product Description
    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
  • Manufacturer
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Manufacturer

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
  • Manufacturer Address
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA Japan
  • Manufacturer Parent Company (2017)
    Mitsubishi Heavy Industries Ltd.
  • Source
    USFDA