Events

Rappel de Horizon Medical Imaging Products Versions 4.6.1 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-00689-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-30
  • 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-00689-1
  • 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 a rare software issue when two or more processes attempt to modify the same image folder within fractions of a second, the write lock mechanism may fail to prevent concurrent modification of the same data. this may result in loss of data within the image folder. as both simultaneous write access and lock mechanism failures are rare, the likelihood of experiencing this problem is very low.
  • Action
    The manufacturer, McKeeson Medical Imaging, will provide a software update to resolve this issue. Until the issue is resolved end users are advised to ensure that all expected images are present in a study prior to completing the Technologist workflow. Thia action has been closed-out on 28/01/2016

Device

Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 1...
  • Modèle / numéro de série
    Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)ARTG Number: 158895
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd