Events

Recall of DISCOVERY NM/CT 670 SYSTEM - NM 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
    17702
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-31
  • 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
    At scan setup during gantry rotation towards scanning position a potential contact between the table-pallet-edge and the detector was identified. such occurances may damage the pallet front-edge and raise concern over potential detector-patient contact. due to the applied force of the device there is potential for serious injury.

Device

DISCOVERY NM/CT 670 SYSTEM - NM GANTRY

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)