Events

Rappel de Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and reviewing haemodynamic parameters (vital signs) in cardiac catheterisation laboratories)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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
    RC-2014-RN-00735-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-04
  • 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-2014-RN-00735-1
  • 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
    Mckesson has identified that its communication to customers regarding the required maintenance tests was insufficient. while each unit has an attached sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 hf4 and earlier versions of the horizon cardiology hemo user guides. if the parameter boxes are not calibrated, the horizon cardiology hemo system may not function properly or potentially affect the accuracy of clinical parameters.
  • Action
    Users are advised that the new version of the User Guide (12.2 version 5.0) is now available to address this issue and will be provided electronically upon request. The attachment provided with the customer letter identifies the updated sections of the new User Guide related to annual maintenance testing. This action has been closed-out on 02/02/2016.

Device

Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and revie...
  • Modèle / numéro de série
    Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and reviewing haemodynamic parameters (vital signs) in cardiac catheterisation laboratories)ARTG number: 146573
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd