Events

Rappel de Elekta MOSAIQ with Evaluate

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 Impac Medical Systems 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
    16720
  • Date de mise en oeuvre de l'événement
    2014-05-19
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Cause
    When using couch move assistant (cma), if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse pointer to a different area of the screen. likewise, if the user hovers the mouse pointer exactly above the site dropdown and uses the mouse thumbwheel or touchpad scroll bar, the site could change and the direction and offset will change depending on the site selected. an inadvertent change can also occur if either the direction or site dropdown is selected, the mouse pointer is anywhere on the dialog, and the mouse thumbwheel or touchpad scroll bar is used.
  • Action
    Software to be upgraded

Device

Elekta MOSAIQ with Evaluate
  • Modèle / numéro de série
    Model: , Affected: , Software version: Versions 1.40 through 2.50, inclusive
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    NZMMDSA