Events

Rappel de Tecotherm Neo (a heating/cooling system for use with infants)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Innervate 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
    RC-2016-RN-00902-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00902-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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)
  • Modèle / numéro de série
    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