Events

Recall of 3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)

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-2016-RN-00176-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00176-1
  • 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 gemflex coil manufactured by neocoil used with ge healthcare 3.0t scanners. part of the cable assembly may overheat when the device is used. there is a rare probability that this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. so far there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users to ensure the user instructions are followed in regards to using proper padding to avoid all direct contact of the patient with the cable. The device can continue to be used while GE are implementing a permanent correction. This action has been closed-out on 23/05/2017.

Device

3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses f...
  • Model / Serial
    3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)Affected Products:3.0T GEM Flex Coil 16-L Array 5430008-23.0T GEM Flex Coil 16-M Array 5430008-33.0T GEM Flex Coil 16-S Array 5430008-43.0T GEM Flex Interface 5430008-5ARTG Number: 153134
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd