Events

Recall of 3.0T GE 6-Channel Phased Array Flex Coil

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-2017-RN-01349-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01349-1
  • 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 has recently become aware of a potential safety issue with the 3.0t 6 channel flex coil used with the 3t mr750w surgical suite scanners. coil overheating can occur when the device is used in mode 2 setup. this could lead to a serious patient thermal injury.To date, there have been no injuries reported as a result of this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    GE Healthcare advised users to discontinue placing coil cables exiting towards the patient's feet. Users can continue to use Mode 1. GE Healthcare have corrected all affected units.

Device

3.0T GE 6-Channel Phased Array Flex Coil

Manufacturer

GE Healthcare Australia Pty Ltd