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
    18523
  • Date de mise en oeuvre de l'événement
    2015-05-14
  • 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
    When vmat control points are distributed with a wider gantry angle spacing than 4 degrees, the dose calculation will not be accurate. such plans will never be generated by raystation and imported plans with this wide gantry angle spacing will normally not be possible to use for dose calculation in raystation. however, if the imported plan is assigned to a vmat enabled machine model with minimum dose rate = 0.00 mu/min and minimum gantry speed = 0.0 degrees/s, it is possible to calculate dose., , depending on the individual plan, local dose inaccuracy in some regions close to the patient surface may range from under a percent to several percent of dose max. the deviation increases with the gantry angle spacing and with the number of affected control points. the problem will mainly occur in the region furthest away from the isocenter.
  • Action
    Software to be upgraded

Device

RaySearch RayStation Radiation therapy treatment planning system
  • Modèle / numéro de série
    Model: RayStation, Affected: , Software version: 2.5, 3.0, 3.5, 4.0
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB