Events

Recall of GEHC Discovery NM/CT 670 Nuclear Medicine System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

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
    RC-2013-RN-00679-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00679-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ge healthcare (hc) is aware of an incident in the united states, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 where the equipment fell onto the patient during the scan. during the investigation, ge have identified a potentially related issue in connection with complaints reported to gehc relating to the discovery nm/ct 670 nuclear medicine system.
  • Action
    While GE Healthcare continues the investigation, GE recommend that facilities immediately cease usage of the Discovery NM/CT system until additional precautionary actions can be performed.

Device

GEHC Discovery NM/CT 670 Nuclear Medicine System

Manufacturer

GE Healthcare Australia Pty Ltd