Events

Recall of GE MRI SystemsDiscovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR355, Twinspeed, Vectra, MR Max, Signa HDx/HDxt/HDi/ 1.5T HDe/Excite-HD 1.5T & 3T/ Excite 1.5T HD, Echospeed & Highspeed/ 1.5T Infinity TwinSpeed, EchoSpeed Plus & HiSpeed Plus/1.0T Infinity HiSpeed Plus & SmartSpeed/EXCITE 3.0T/ EXCITE 3.0T HD/ Excite 1.5T TwinSpeed & EchoSpeed, HiSpeed & SmartSpeed/ Excite 1.5T/ Excite 3.0T/ Contour/I / OpenSpeed/ Profile /Ovation / PET/MR

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-2015-RN-00265-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00265-1
  • 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
    It has come to the attention of ge healthcare systems that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. the most recently deployed on-site software version may include safety updates.
  • Action
    It has come to the attention of GE Healthcare that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates that would be absent if a previous version was installed. This action has been closed-out on 05/08/2016.

Device

GE MRI SystemsDiscovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR...
  • Model / Serial
    GE MRI SystemsDiscovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR355, Twinspeed, Vectra, MR Max, Signa HDx/HDxt/HDi/ 1.5T HDe/Excite-HD 1.5T & 3T/ Excite 1.5T HD, Echospeed & Highspeed/ 1.5T Infinity TwinSpeed, EchoSpeed Plus & HiSpeed Plus/1.0T Infinity HiSpeed Plus & SmartSpeed/EXCITE 3.0T/ EXCITE 3.0T HD/ Excite 1.5T TwinSpeed & EchoSpeed, HiSpeed & SmartSpeed/ Excite 1.5T/ Excite 3.0T/ Contour/I / OpenSpeed/ Profile /Ovation / PET/MRARTG: 223115
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd