Events

Recall of DISCOVERY PET/CT 600 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
    48593
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-29
  • 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
    A software issue exists when using list mode replay such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions.

Device

DISCOVERY PET/CT 600 SYSTEM - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)