Events

Recall of IMRIS OR TABLE MODEL ORT100

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
    26000
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-10
  • 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
    Additional labelling is being added to the ort100 and ort200 tables specifying that the table is mr conditional. the user manuals are also being updated to reflect this change.

Device

IMRIS OR TABLE MODEL ORT100
  • Model / Serial
    Model Catalog: N/A (Lot serial: all serial numbers); Model Catalog: (Lot serial: all serial numbers)
  • Product Description
    ORT100
  • Manufacturer
    IMRIS INC.

Manufacturer

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