Events

Recall of Device Recall MHITM2000/ VERO"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hitachi Ltd., Medical System Operations Group.

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
    79439
  • Event Risk Class
    Class 2
  • Event Number
    Z-1585-2018
  • Event Initiated Date
    2017-12-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162328
  • 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
    Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
  • Action
    Hitachi sent a Field Safety Notice letter dated November 28, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter includes instructions for the user on how to verify patient position even with the software issue. The letter also explains that correction software is being developed with a tentative release date of, "End of January, 2018.". A customer service representative will contact affected customers about installing the software. For questions contact your our Customer Service Representative.

Device

Device Recall MHITM2000/ VERO"
  • Model / Serial
    Serial Number: 203919
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the state of NY.
  • Product Description
    MHI-TM2000 Linear Accelerator System || Product Usage: || 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
    Hitachi Ltd., Medical System Operations Group

Manufacturer

Hitachi Ltd., Medical System Operations Group
  • Manufacturer Address
    Hitachi Ltd., Medical System Operations Group, 2-1, Shintoyofuta, Kashiwa Japan
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    USFDA