Events

Recall of ECG Electrode

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Atris 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-2015-RN-01099-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01099-1
  • 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
    In response to feedback from the field, it was discovered that there is a risk ecg electrodes of specific lots fail to transmit signals. the investigations initiated confirmed the defect and permitted to identify further, potentially affected products.This action was undertaken prior to consultation with the tga.
  • Action
    Artis is advising users to decard any remaining stock.

Device

ECG Electrode
  • Model / Serial
    ECG ElectrodeArticle Number: 50007, 50547, 58046, 58051, 58198, 58205, 58688, 58789, 58872, 58995, 59356, 59629Mulitple lot numbers affected
  • Manufacturer
    Atris Pty Ltd

Manufacturer

Atris Pty Ltd