Events

Recall of Device Recall MHITM2000/ VERO (TM)

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
    65786
  • Event Risk Class
    Class 2
  • Event Number
    Z-1931-2013
  • Event Initiated Date
    2013-06-21
  • Event Date Posted
    2013-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120158
  • 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: 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.
  • Action
    The firm, Mitsubishi Heavy Industries, Ltd. (MHI), sent an "URGENT FIELD SAFETY NOTICE" letter dated June 21, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: If any minor failure occurs, please always press [ALARM RESET] button on operator console first; and if [EXIT] button is clicked after a minor failure occurs, please click [YES] on the pop up dialog to finish treatment completely. MHI is developing a correction for this issue. Tentatively planned availability date: End of October 2013. The correction will be free of charge and a MHI Customer Service representative will contact affected customers to schedule its installation as the correction becomes available. If you need any further information or support concerning this issue, please feel free to contact our Customer Service representative: VERO GmbH, Kapellenstrasse 12, 8566 Feldkirchen Germany, at +49-89-99-1568-44 or email: franz.gum@vero-sbrt.com.

Device

Device Recall MHITM2000/ VERO (TM)
  • Model / Serial
    Serial Numbers #s 201902 and 203901
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
  • Product 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
  • 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