Events

Recall of Natus Medical EEG Machines using Neuroworks v8.5 software

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare 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-00575-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00575-1
  • 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
    There have been multiple vulnerabilities discovered in natus neuroworks software, which is used in natus xtek eeg medical products. the vulnerable devices contain an ethernet connection for data acquisition and connection to networks. under certain scenarios, these vulnerabilities allow a remote attacker to run arbitrary code on the device, including a denial of service attack.
  • Action
    Life Healthcare is advising that this issue is resolved in an updated software version - Neuroworks 8.5 GMA2. This software will be installed for users by Life Heathcare either on-site or via remote access depending on system setup.

Device

Natus Medical EEG Machines using Neuroworks v8.5 software
  • Model / Serial
    Natus Medical EEG Machines using Neuroworks v8.5 softwareARTG Number: 197550(Life Healthcare Pty Ltd - Electroencephalograph)
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd