Events

Recall of Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound 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-01095-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01095-1
  • 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
    During procedures where the 4d tee (6vt-d) probe is used over an extended period of time, the vivid e9 scanner may gradually become unresponsive with the result that the vivid e9 scanner must be rebooted. this event may lead to possible risk to patients, when performing transoesophageal echocardiography (tee).
  • Action
    GE Healthcare is providing a correction to be installed by a GE service engineer. End users are advised to reboot the scanner if it becomes unresponsive. A reboot should take approximately 2 minutes.

Device

Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system)
  • Model / Serial
    Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system) Affected serial numbers: between VE94165 and VE95415ARTG Number: 146317
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd