Events

Recall of Natus NicoletOne 32Ch Ambulatory EEG Record System

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-00141-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00141-1
  • 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 supplier, natus has discovered a scenario that incorrectly allows customers using nicvue to import an ambulatory exam into a patient for whom the exam was not started. in the event that after starting an ambulatory exam, the recorder application does not shutdown correctly, an empty exam file is left in the patient exam list in nicvue. with this empty exam file present, no internal check is done to ensure the patient id on the ambulatory’s sd card matches the selected patient in nicvue, resulting in the exam on the sd card being imported into the patient record that is currently selected in nicvue. the register.Exe application will bypass the patient id check on the card of the selected patient and allow the exam to be registered into any selected patient.
  • Action
    LifeHealthcare is advising users to ensure the recorder is only shutdown via the Recorder UI, either from the File menu or the X button. If the issue occurs, the empty exam can be deleted from NicVue prior to importing the ambulatory exam. LifeHealthcare will be conducting training for relevant staff regarding this issue, and providing users with an updated copy of the Instructions for Use.

Device

Natus NicoletOne 32Ch Ambulatory EEG Record System
  • Model / Serial
    Natus NicoletOne 32Ch Ambulatory EEG Record SystemSerial Number: MBR160952ARTG Number: 294968
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd