Events

Rappel de Cook Test Tube Heater, power supply unit

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par William A Cook Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    17248
  • Date de mise en oeuvre de l'événement
    2014-09-02
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Cause
    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