Events

Recall of OPTIMA CT 540 - GANTRY

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
    127109
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-11
  • 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
    There is a possibility while specific workflow to create a film image with one patient's images and another patient's name in the footer. there is also an issue when within manual film compose if a color iamge is selected for printing another patient's black and white image appears in the preview screen and the color image cannot be printed.

Device

OPTIMA CT 540 - GANTRY

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)