Events

Recall of SIGNA Creator and SIGNA Explorer (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-01212-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01212-1
  • 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
    The function of rf power monitor is to monitor the rf amplifier output power, and detect if rf transmit power exceeding the predicted amount is generated. if the rf amplifier output power exceeds the predicted sar (specific absorption rate) amount, the rf power monitor will stop the scan. if the user performs a tps (transceiver processing and storage) reset during a patient scan, the rf power monitor will be disabled for the remainder of that patient scan. this would prevent the power monitor from detecting any subsequent failure of rf transmit function. these two failures together, could result in higher than expected thermal dose to the patient and higher than expected localised heating. there have been no failures of this type reported, and no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users they may continue to use the system, but ensure the RF power monitor is re-enabled by initiating a new patient exam if a TPS reset is performed during a patient exam. A software upgrade will be installed as a permanent correction. This action has been closed-out on 18/05/2017.

Device

SIGNA Creator and SIGNA Explorer (MRI System)

Manufacturer

GE Healthcare Australia Pty Ltd