Events

Rappel de Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiology (MR) 12.0 and 12.1.1(Radiology Picture archiving and communication 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-2016-RN-00226-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-01
  • 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-00226-1
  • 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 under rare circumstances, imported images and/or studies may re-use a non-unique image directory.This issue may cause incorrect images to be displayed for a patient. it is possible that clinical decisions will be made using an incorrect set of images. if undetected, in the worst case this may result in inappropriate care leading to potential patient harm.
  • Action
    The sponsor DTA will contact the affected customers and arrange for the implementation of a software upgrade which will resolve the reported issue.

Device

Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiol...
  • Modèle / numéro de série
    Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiology (MR) 12.0 and 12.1.1(Radiology Picture archiving and communication system)ARTG Number: 158895
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd