Events

Rappel de Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (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-00101-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-01-28
  • 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-00101-1
  • 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
    During the archive procedure, if the system begins to archive images for multiple studies within fractions of a second and an unexpected condition causes the software process restart the following issues may occur:1. incorrect images being displayed for a study retrieved from archive (for example, a study for a different patient being displayed),2. failure to retrieve images for a study from archive.If this issue occurs, two or more studies may be affected. this issue is not immediately evident to the user at the time of archival. it is possible that clinical decisions will be made using an incorrect set of images or an incomplete set of images. this may result in inappropriate care leading to patient harm if unnoticed or a need to retake images.
  • Action
    Device Technologies is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology pic...
  • Modèle / numéro de série
    Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology picture archiving and communication system)ARTG Number: 158895
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd