Events

Recall of Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (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-2014-RN-01067-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01067-1
  • 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 epi2alt feature which is a type-in pulse sequence database (psd) recently introduced in the dv25 software release that was intended to help a different brand users transitioning to ge scanners, contains a software issue in which images may be flipped and annotated incorrectly. this image orientation error will affect all axial, sagittal, and coronal diffusion-weighted echo planar imaging (epi) scans using the ‘epi2alt’ type-in (psd) in conjunction with the ‘focus excitation’ option when the number of excitations (nex) is set to larger than 1. no other psds or imaging options are affected by this issue. no injuries have been reported due to this issue.
  • Action
    GE Healthcare recommends that users discontinue use of the type-in ‘epi2alt’ PSD option. Users may continue to use all diffusion-weighted EPI scans available through the user interface.

Device

Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with t...
  • Model / Serial
    Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System)ARTG Number: 223115
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd