Events

Rappel de RaySearch Raystation

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 RaySearch Laboratories AB.

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
    19767
  • Date de mise en oeuvre de l'événement
    2016-02-15
  • 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: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Cause
    This notice concerns an issue found with some of the tools used for drawing in and interacting with the patient views and beam's eye views. the issue concerns all tools that are used with the left mouse button held down. these tools can become unsynchronized with the stored data if other commands such as for example a right mouse click are used at the same time as the left mouse button is held down., actions to be taken:, 1. always release the left mouse button before using other keys or mouse buttons ., 2. if the warning message "temporary items should not be visible on approval¨ is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the plan approval dialog, or close and reload the patient case and review the structures again.
  • Action
    Software to be upgraded

Device

RaySearch Raystation

Manufacturer

RaySearch Laboratories AB