Events

Rappel de Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Carestream Health 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-2013-RN-01022-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-03
  • 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-2013-RN-01022-1
  • 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
    Carestream health australia has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios.This problem occurs infrequently and only when all of the following conditions are met:1) the version installed is v11.3.2 or v11.3.2.4 or v11.42) the exam type is from multi-slice modalities3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images.4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
  • Action
    Users are advised that the software patch will be installed by Carestream Health Australia's engineers to address the problem. Users are also informed that should a user notice the problem prior to deployment of a permanent fix, it can easily be resolved by reapplying the same display protocol.

Device

Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4
  • Modèle / numéro de série
    Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4Catalogue number & description:1308519 VIRT PWR Reading Basic SW Workgroup1530633 VIRT PWR Reading Basic SW 8 Pack1467067 Virtual Reading Basic SW Workgroup1405794 Virtual Reading Basic SW 8 Pack8171837 Virtual Enterprise SW StandaloneARTG Number: 135310
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd