Events

Recall of REVOLUTION CT - 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
    74232
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-19
  • 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 become aware that an out of tolerance torque tool was used on three joints on revolution ct system during the manufacturing process. if the x-ray tube becomes loose on the ct gantry during operation this could result in beam tracking errors potential scan aborts and/or a possible image artifact. there is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. there have been no injuries reported as a result of this issue.

Device

REVOLUTION CT - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)