Events

Recall of OR TABLE ORT 300

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

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
    73980
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-25
  • 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
    One of the 3 pins to hold an alignment block to the floor of the mr suite was missing until during testing on the weekend the missing pin was pulled into the magnet damaging the image quality phantom andheadrest extension.

Device

OR TABLE ORT 300
  • Model / Serial
    Model Catalog: 114093-000 (Lot serial: part # 114093-000)
  • Product Description
    OR Table ORT300
  • Manufacturer
    IMRIS INC.

Manufacturer

IMRIS INC.
  • Manufacturer Address
    WINNIPEG
  • Manufacturer Parent Company (2017)
    IMRIS Inc
  • Source
    HC