Events

Rappel de Centricity PACS RA1000 Workstation versions 3.2 and higher (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 IITS 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-00442-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-15
  • 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-00442-1
  • 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
    It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the centricity pacs ra1000 workstation and images are rejected from the active displayed study, images from the previously displayed study may also be rejected. this issue can occur with a previously displayed study that remains open in the background.There is a delrejimg task in centricity pacs versions 3.2 and higher, that if enabled and running, in conjunction with the inadvertently rejected image issue, poses a potential patient safety hazard due to data loss. if the delrejimg task runs, the inadvertently rejected images will be permanently deleted from pacs. if you do not have the delrejimg task running, there is no potential hazard since the inadvertently rejected images remain on the system. the deletion of the inadvertently rejected images could result in missed intervention or mis-diagnosis. no patient injuries have been reported.
  • Action
    A future release of Centricity PACS will address the unintentional rejected image issue. Until the permanent fix for this issue is deployed, GE recommends customers implement workarounds identified in the customer letter. Also, a GE Healthcare service representative will remove the DelRejImg task from the task table in the Centricity PACS database. This will remove the rejected image deletion feature, and eliminate the hazard situation. Thia action has been closed-out on 28/01/2016.

Device

Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication s...
  • Modèle / numéro de série
    Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication system)Software versions: 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 3.2 SP7, 3.2 SP8, 4.0, 4.0.1 & 4.0 SP3ARTG number: 162031
  • Manufacturer
    GE Healthcare IITS Australia Pty Ltd

Manufacturer

GE Healthcare IITS Australia Pty Ltd
  • Source
    DHTGA