Events

Recall of DISCOVERY IGS 730 SYSTEM - 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
    26301
  • Event Risk Class
    III
  • Event Initiated Date
    2015-01-12
  • 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
    Systems may experience an unintentional motion or rotation due to a positioning user interface issue. the potential reversed motion of the gantry/table has been observed when the user positions the joystick at its maximum position (end of travel) on the smart box. the unintended reversal of the direction of the motion may lead to a collision of the table or c-arm with medical instruments patient or personnel and result in injury.

Device

DISCOVERY IGS 730 SYSTEM - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)