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
    23769
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-11
  • 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
    Ge healthcare has recently become aware of a potential safety issue with gas venting. a site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. there have been no injuries reported as a result of this issue. at this site a magnet heater probe connection became disconnected. this resulted in ice build-up within the magnet blocking the cryogen vent. since the vent was blocked by ice the later magnet quench caused gas to be vented into the magnet room.

Device

OPTIMA MR430S 1.5T - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)