Events

Recall of Discovery IGS 730

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-2018-RN-00332-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00332-1
  • 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
    Ge healthcare has become aware of a potential loss of imaging mode during an interventional procedure using the discovery igs 730. the discovery igs and innova igs systems may experience x-ray abort errors during a real-time interventional procedure. this issue could potentially happen before or during fluoroscopic use and could result in the loss of imaging capability.To date, there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising that they will be in contact with affected users to arrange installation of the correction.

Device

Discovery IGS 730
  • Model / Serial
    Discovery IGS 730 ARTG Number: 93871(GE MEDICAL SYSTEMS, AUSTRALIA LTD X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd