Events

Recall of Optima MR430s and MSK 1.5T Extreme (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-00346-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00346-1
  • 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 ge extremity 1.5t mr scanners use a liquid coolant to protect the gradient coil inside the magnet from heating. if the coolant supply lines are assembled incorrectly, they may leak the liquid onto the floor which may result in a slippery surface and fall hazard.
  • Action
    GE is correcting the affected units and is asking users to monitor for leakage until the units are corrected.

Device

Optima MR430s and MSK 1.5T Extreme (MRI System)
  • Model / Serial
    Optima MR430s and MSK 1.5T Extreme (MRI System)Scanner identification numbers between '06 01 2008-001' and '01 13 2013-001' (format "mm dd yyyy-nnn")ARTG Number: 193173
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd