Events

Recall of Revolution CT Scanners, software version 15MW03.12

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-01058-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01058-1
  • 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
    A potential hazardous situation can occur during a routine head scan with possible artefacts that may emulate pathology between the brain tissue and bone in the head images. no injuries have been reported to date related to this issue.
  • Action
    To minimise the effects of beam hardening artefacts during routine head scans, GE Healthcare recommends that in addition to the information in the existing CT User Manual, the site also follow the additional recommendations identified in the customer letter. GE Healthcare will be delivering an addendum to the User Manual that reiterates these mitigations. Additional improvements to image quality are currently in development. This software will be distributed and installed on affected systems. This action has been closed-out on 29/08/2016.

Device

Revolution CT Scanners, software version 15MW03.12

Manufacturer

GE Healthcare Australia Pty Ltd