Events

Recall of ECG Electrode SKINTACT W-60

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtel 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-01102-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01102-1
  • 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
    It was discovered that there is a risk that the abovementioned affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date. it is very unlikely that this will cause a patient risk.
  • Action
    Medtel is advising users to inspect stock and quarantine any remaining units. Affected product will be replaced by unaffected units. This action has been closed-out on 25/08/2016.

Device

ECG Electrode SKINTACT W-60
  • Model / Serial
    ECG Electrode SKINTACT W-60Catalogue Number: 58051Lot Numbers: 40414-0325, 40722-0328, 40918-0321, 40414-0325, 40305-0325, 31216-0158ARTG Number: 135457
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA