Recall of Discovery MR750w

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-2018-RN-00721-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-19
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. to date, no injury has been reported to ge as a result of this issue.
  • Action
    GE is advising they will be in contact with users to arrnage for impacted products to be corrected. In the interim, users may continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning. If a brown discolouration is seen on the inner surface of the patient bore, or if a burning smell is noticed, please contact the local GE Service Representative.

Device

  • Model / Serial
    Discovery MR750w ARTG Number: 223115(GE Healthcare Australia Pty Ltd - MRI system, full-body, superconducting magnet)
  • Manufacturer

Manufacturer