Events

Rappel de Ultrasound system, imaging, cardiovascular

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Vingmed Ultrasound AS.

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
    21236
  • Date de mise en oeuvre de l'événement
    2017-03-20
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    The manufacturer has become aware of an issue where a patient other than the 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.
  • Action
    Software to be upgraded

Device

Ultrasound system, imaging, cardiovascular
  • Modèle / numéro de série
    Model: , Affected: 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 63.0, Vivid S70N/S60N with software version 201, revision 63.0
  • Manufacturer
    GE Vingmed Ultrasound AS

Manufacturer

GE Vingmed Ultrasound AS