Events

Recall of OPTIMA MR360 - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GE HEALTHCARE CANADA 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
    25278
  • Event Risk Class
    III
  • Event Initiated Date
    2011-05-27
  • 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
    Optima mr360 1.5t: in the event of a significant power surge such as one that might be caused by a lightning strike or a utility equipment failure there is a possibility that the fuse in the mru could be affected. this situation could indirectly lead to a potential hazard if an emergency magnet quench is required.

Device

OPTIMA MR360 - MAIN UNIT
  • Model / Serial
    Model Catalog: 5312366 (M50002BB) (Lot serial: 1591211)
  • Product Description
    OPTIMA MR360 1.5T
  • Manufacturer
    GE HEALTHCARE CANADA INC.

Manufacturer

GE HEALTHCARE CANADA INC.