Events

Rappel de RaySearch RayStation - Radiation therapy treatment planning system

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
    15008
  • Date de mise en oeuvre de l'événement
    2013-07-17
  • 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
    As issue has been identified in the raystaion 3.0 and 3.5 dose volume statistics calculation. under certain conditions resampling of regions of interest (roi) geometries to the dose grid representations is not correctly calculated and an additional voxel layer is added incorrectly on the superior side of each roi., the problem is pronounced for very small rois, leading to a possible over estimation of the dose maximum or a possible under estimation of the dose minimum, thus always erring on the safe side. worst-case scenario is delivering less dose than optimal to target organs.
  • Action
    Manufacturer to issue advice regarding use

Device

RaySearch RayStation - Radiation therapy treatment planning system

Manufacturer

RaySearch Laboratories AB