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
    68909
  • Event Risk Class
    Class 2
  • Event Number
    Z-2653-2014
  • Event Initiated Date
    2014-07-05
  • Event Date Posted
    2014-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128998
  • 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: if a user changes the calendar setting from workday to holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become treated (completed) status on the exact day when such change is made, to untreated status. furthermore, such treatment would be cloned and mistakenly added to the schedule as untreated treatment.
  • Action
    A Preliminary Customer Information Letter (dated 7/4/14) was emailed to customers on 7/05/14 from Mitsubishi's sales and service representative in Germany. The letter informed customers of the potential safety issue associated with the VERO Linear Accelerator and the recommended actions to be taken. A formal URGENT FIELD SAFETY NOTICE Letter (dated 7/15/14) was emailed to customers on 8/07/14 from Mitsubishi's sales and service representative in Germany. The letter instructed customers to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions to be taken.

Device

Device Recall VERO Linear Accelerator System
  • Model / Serial
    Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of NY, FL, and TX.
  • Product Description
    VERO Linear Accelerator System, Model Number MHI-TM2000; 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