Events

Recall of Tecotherm Neo (a heating/cooling system for use with infants)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Innervate 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-2016-RN-00902-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00902-1
  • 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 has been identified that the self-test conducted immediately after switching on the device is evaluated as failed although everything would work correctly. users would see a message that says a serious internal malfunction has occurred and after 30 seconds the device would automatically switch off. this is a result of a defect with the main circuit board.
  • Action
    Niche Medical is advising users that if the device starts up as normal, it is safe to continue to use. If the error occurs, it is recommended users use an alternative device or method. Niche Medical will be implementing a software upgrade as a permanent correction. This action has been closed-out on 16/02/2017.

Device

Tecotherm Neo (a heating/cooling system for use with infants)
  • Model / Serial
    Tecotherm Neo (a heating/cooling system for use with infants) Serial numbers: 2016/11/10 and belowARTG Number: 192036
  • Manufacturer
    Innervate Pty Ltd

Manufacturer

Innervate Pty Ltd