Events

Rappel de Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12.0 (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-2014-RN-00610-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-03
  • 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-00610-1
  • 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, mckesson has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images. this discrepancy occurs on a very small percentage of studies, and may result in the following:- a small number of images, typically a single image, in an individual study may be lost or unavailable; and/or- the study is not archived in long-term storage without manual correction of the discrepancy.If the issue occurs, it is possible that clinical decisions will be made using an incomplete set of images. this may result in inappropriate care leading to patient harm and/or a need to retake images.
  • Action
    McKesson will provide a resolution to this issue through a software update which may require changing your software version. A Device Technology Australia representative will contact customers to organise the software upgrade. Thia action has been closed-out

Device

Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12....
  • Modèle / numéro de série
    Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)ARTG Number: 158895 (TBC)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd