Events

Rappel de IntelePACS InteleViewer with software version 3-5-1 to 4-15-1

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2017-RN-01234-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-28
  • 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-2017-RN-01234-1
  • 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
    Following a complaint from a client, intelerad is notifying users of a problem that could occur on their intelepacs software. the magnification tool functionality may display incorrect images if the user is utilising reverse ordering. in this instance, the image shown in the tool will not be the one in the current viewport. the tool may be displaying a magnified image for a different slice of the series. this software defect could lead radiologists to delay their diagnosis/report. there have been no injuries reported as a result of this issue.
  • Action
    Emergo is advising users to be aware of this issue. A software correction will be implemented to rectify the issue.

Device

IntelePACS InteleViewer with software version 3-5-1 to 4-15-1

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia