Events

Recall of OPTIMA MR430S 1.5T - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    45809
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-26
  • 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
    Magnet rundown unit (mru) may not be connected to the magnet. if the mru is disconnected the mru will not function as expected and will not quench the magnet when the button is pressed. in emergency situations a disconnected mru could delay removal of a ferrous object from the magnet potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times.

Device

OPTIMA MR430S 1.5T - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)