Events

Recall of Test Tube Heater - Power Supply UnitTest Tube Heater

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia 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-2014-RN-00924-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00924-1
  • 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 power supply of the devices are being replaced because recent testing of the combination of the test tube heater and power supply was found to exceed the prescribed electromagnetic compatibility (emc) limits for radiated emissions.As the level of excess emissions are only slightly over the prescribed limits, and because the exposure to the radio frequency (rf) fields is far below internationally accepted safety levels, it is unlikely that there are any health risks to the user or patient posed by the non-conforming combination of the test tube heater (k-fth-1012) and power supply (k-aps-300). it is also unlikely for the power supply to affect the operation of the test tube heater as this device is designed to have rf immunity greater than the radiation emitted by the power supply.
  • Action
    William A. Cook Australia will provide an alternative power supply unit. End users are requested to discontinue use and destroy the affected units. This action has been closed-out on 01/03/2016.

Device

Test Tube Heater - Power Supply UnitTest Tube Heater
  • Model / Serial
    Test Tube Heater - Power Supply UnitTest Tube Heater Part Number: K-FTH-1012Power Supply Unit Part Number: K-APS-300ARTG Number: 140546
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd