Events

Recall of OPTIMA CT660 - 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
    26758
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-18
  • 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
    The recall was intitiated due to a potential safety issue that may occur when direct multi-planar reformat series and screen saved images are sent to some pacs. the dmpr and screen save funtionality may possibly generate the same series uid. it has been seen that some pacs may combine series under a patient using onlt the series uid resulting in images from different patient(s) to appear in one exam.

Device

OPTIMA CT660 - GANTRY

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)