Events

Rappel de Multiple Vivid Ultrasound Products Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0 Vivid S70/S60 with software version 201, revision 55.0 and 63.0Vivid S70N/S60N with software version 201, revision 63.0

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-2017-RN-00390-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-23
  • 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-00390-1
  • 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
    An issue has been identified whereby another patient other than the one intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. this issue could lead to misdiagnosis. to date, there have been no injuries reported because of this issue.
  • Action
    GE Healthcare is advising users to follow the "Safety Instructions" as detailed in their recall notification letter. Users are further advised that a GE Healthcare representative will contact them to arrange for a free correction of all affected products.

Device

Multiple Vivid Ultrasound Products Vivid E95/E90/E80 with software version 201, revision 54.0 and...
  • Modèle / numéro de série
    Multiple Vivid Ultrasound ProductsVivid E95/E90/E80 with software version 201, revision 54.0 and 61.0Vivid S70/S60 with software version 201, revision 55.0 and 63.0Vivid S70N/S60N with software version 201, revision 63.0ARTG Number: 146317
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd