Events

Recall of Discovery MR750w (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-2016-RN-00773-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00773-1
  • 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 patient bore heating on the discovery mr750w. 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. this issue has been observed in the situation in which a user has routinely used the system for off center imaging with large patients (for example, off center wrist or shoulder exams) with transmit gain set near maximum levels. there have been no reports of injury as a result of this issue.
  • Action
    GE is advising users to continue to use the system and follow the existing Operator 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, discontinue scanning. GE will be correcting all affected units.

Device

Discovery MR750w (MRI System)

Manufacturer

GE Healthcare Australia Pty Ltd