Events

Recall of Discovery MR450, MR750 and Optima MR450w MRI 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-00885-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00885-1
  • 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 due to exposed yellow foam on the end bells of discovery mr450, mr750 and optima mr450w product. the yellow foam strip used between the end bell covers and patient bore of certain ge mr products may extend past the surface of the covers. the foam itself is not hazardous. however, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another.
  • Action
    GE Healthcare is advising users that the system may continue to be used as normal even with the yellow foam protruding from the bore. Patient padding should be used as described in the Operating manuals and cleaning practices described in the Operating manuals should be followed. Patient padding will minimise contact with the foam and users are advised not to attempt to remove the foam. GE Healthcare will be installing a permanent cover over the foam in October 2013.

Device

Discovery MR450, MR750 and Optima MR450w MRI System

Manufacturer

GE Healthcare Australia Pty Ltd