Events

Recall of Device Recall VERO

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
    73436
  • Event Risk Class
    Class 2
  • Event Number
    Z-1308-2016
  • Event Initiated Date
    2016-03-07
  • Event Date Posted
    2016-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144310
  • 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
    In rare cases the vero/mhi-tm2000 operator console could set an incorrect gantry angle for the first beam of an imrt treatment if certain specific conditions are met. if gantry angle for the first beam of imrt is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.
  • Action
    A Field Safety Notice dated March 2, 2016, was sent to all affected customers via e-mail on March 7, 2016. The Field Safety Notice informed users of the problem and provided a safe workaround until corrected software is available. The correction will be free of charge and a Customer Service Representative will contact all affected customers to schedule its installation. Customers with questions were advised to contact their Customer Service Representative.

Device

Device Recall VERO
  • Model / Serial
    Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including New York, Texas, Florida, and Ohio
  • Product Description
    VERO MHI-TM2000 Linear Accelerator System --- 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