Events

Recall of Nicolet EEG Wireless Amplifier

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-2013-RN-00351-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00351-1
  • 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 nicolet eeg wireless amplifier may overheat and become uncomfortable to touch around the area of the on/off button. the overheating may result in discomfort ranging from too hot up to the potential for a burn.
  • Action
    Life Healthcare is recalling the affected product and replacing it with unaffected stock.

Device

Nicolet EEG Wireless Amplifier
  • Model / Serial
    Nicolet EEG Wireless AmplifierPart Number: VIA-982A0577ARTG Number: 179362
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd