Events

Recall of Cook Test Tube Heater, power supply unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    17248
  • Event Initiated Date
    2014-09-02
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • 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
    Product to be exchanged

Device

Cook Test Tube Heater, power supply unit

Manufacturer

William A Cook Australia Pty Ltd