Events

Recall of Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)

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-2014-RN-00464-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00464-2
  • 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 patient table cradle emergency release handle and cradle release block mechanism of certain ge mri products. patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. this could make difficult the safe removal of the patient from the system.
  • Action
    GE Healthcare will correct all affected products. Before continued use prior to repair, GE is advising that the operator should assess patient positioning and ease of egress and cease use if cradle movement for egress is impeded. If the operator encounters difficulty in moving the cradle out because the cradle release handle does not release properly or if the cradle movement is impeded, the facility’s GE Healthcare Service Representative should be contacted so that the cradle can be inspected and necessary repairs can be made as soon as possible. This action has been closed-out on 02/02/2016.

Device

Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Dis...
  • Model / Serial
    Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)ARTG Number: 108415
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd