Events

Rappel de RaySearch 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
    20610
  • Date de mise en oeuvre de l'événement
    2016-09-06
  • 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
    Two issues have been identified with the dose calculation when using a region of interest (roi) of type fixation or support with material override within the patient outline in raystation models., 1. when an roi with material override overlaps a fixation or support roi, the material used for dose calculation in the overlapping region may not be as intended., 2. when a support or fixation roi overlaps the patient outline (external roi) in a dose grid voxel along the outer surface of the patient outline, the density used for dose calculation in that voxel may not be as intended.
  • Action
    Instructions for use to be updated

Device

RaySearch Radiation Therapy Treatment Planning System
  • Modèle / numéro de série
    Model: 2.5, 3.0, 4.0, 4,5, 5.0 and 4.3 and InverseArc 1.0, Affected:
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB