Events

Rappel de Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)

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-00962-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-04
  • 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-00962-1
  • 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
    The manufacturer has identified two scenarios in which the mckesson cardiology hemo calculation section incorrectly converts the haemoglobin value before it is utilized in the applicable formula calculations. as a result, the formula output is incorrect. if the issue occurs, then for those procedures that use the specified formula calculations, the formula outputs will be incorrect. this may lead to delay in appropriate treatment or incorrecttreatment.
  • Action
    McKesson will provide a resolution to this issue through a software update. A system check will also take place to identify any previous procedure calculations that may have been affected in your facility. Until the correction is completed additional procedures to ensure correct Hb values are requested to be carried out by end users. This action has been closed-out on 07/06/2016.

Device

Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)
  • Modèle / numéro de série
    Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)ARTG Number: 146573
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd