Events

Recall of HAMILTON-T1 Transport Ventilator, Software version 1.1.2

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AHC Solutions 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-00025-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00025-1
  • 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
    Higher than expected internal oxygen consumption of the hamilton t1 transport ventilator may cause miscalculation of the required oxygen supply for paediatric patient transport situations with long timeframe applications where the oxygen supply may be limited or finite.
  • Action
    AHC Solutions Pty Ltd (the sponsor) is providing amended instructions describing the process required to calculate the correct oxygen requirement prior to transport. Hamilton Medical (the manufacturer) will provide a software update to correct the issue.

Device

HAMILTON-T1 Transport Ventilator, Software version 1.1.2

Manufacturer

AHC Solutions Pty Ltd