Events

Recall of MHI-TM2000 LINEAR ACCELERATOR SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HITACHI LTD..

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
    88692
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Due to system controller software anomaly the ring rotation and/or couch shift for patient positioning deviation correction may not be applied.

Device

MHI-TM2000 LINEAR ACCELERATOR SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: MHI-TM2000 (Lot serial: all lots.)
  • Product Description
    MHI-TM2000 Linear Accelerator System
  • Manufacturer
    HITACHI LTD.

Manufacturer

HITACHI LTD.
  • Manufacturer Address
    TOKYO
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    HC