Events

Rappel de Vital Images Vitrea Enterprise Suite, VitreaAdvanced, VitreaCore and Vitrea fX

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 Vital Images Inc.

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
    14241
  • Date de mise en oeuvre de l'événement
    2013-02-22
  • 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: Canon Medical Systems ANZ Pty Limited, Building 2, Level 1 Central Park, 666 Great South Road, Penrose, AUCKLAND 1051
  • Cause
    Manufacturer has found an error regarding measurement. this error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/xial plane (rotation around the z-axis), while not being simultaenously rotated around the x-axis and y-axis. manufacturer has found that this orientation adjustement to occur on rare occasions, such as to straighten tilts in head or neck scans, sually with minimal efect on measurements, but sometimes resulting in differences in mength measurement of up to 29% and in volume measurements of up to 50%.
  • Action
    Software to be upgraded

Device

Vital Images Vitrea Enterprise Suite, VitreaAdvanced, VitreaCore and Vitrea fX
  • Modèle / numéro de série
    Model: , Affected: prior to version 6.3.3 except 6.1.6, 6.2.3 and 6.3
  • Manufacturer
    Vital Images Inc

Manufacturer

Vital Images Inc
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    NZMMDSA