Events

Recall of SIGNA Pioneer 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-00242-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00242-1
  • 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
    There is a potential safety issue with a missing ferrous warning label on the signa pioneer table control box (tcb).Ferrous material in the tcb could cause unexpected attraction to the mr system’s high-strength magnetic field during servicing activities. this could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the tcb from the magnetic field. there have been no events reported as a result of this issue. clinical scanning of patients is not affected by this safety notification.
  • Action
    GE Healthcare will correct all affected products at no cost to the affected customers by applying the ferrous warning label to the TCB. These labels are expected to be available and installed by June 2016. A GE Healthcare representative will contact the affected customers to arrange for the correction.

Device

SIGNA Pioneer MRI System

Manufacturer

GE Healthcare Australia Pty Ltd