Events

Rappel de Centricity PACS RA1000 Workstation (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 GE Healthcare 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-00868-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-08-26
  • 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-00868-1
  • 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
    Ge healthcare has become aware of potential safety issues due to out of context and measurement issues associated with specific workflows of centricity pacs ra1000 workstations.
  • Action
    GE Healthcare are providing a software update to correct the issue (version 4.0 SP3).The update can only be applied to versions 3.2.X and 4.01. Customers on previous versions must first upgrade to 3.2 before applying update 4.0 SP3. Once 4.0 SP3 (FMI 85285) is released, all media required to upgrade from 3.1.1.2 to 3.2 to 4.0 SP3 are included in the FMI 85285 media kit. Thia action has been closed on 28/01/2016

Device

Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)
  • Modèle / numéro de série
    Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)All Versions below 4.0.3ARTG Number: 120196
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd