Events

Rappel de RaySearch RayStation 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
    20245
  • Date de mise en oeuvre de l'événement
    2016-06-07
  • 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
    An issue has been found with the treatment plan report in raystation 5. for a treatment plan with multiple beam sets, the table for roi plan dose statistics in the report may show the statistics for a beam set dose. the error can only be triggered when using a report template where statistics for a beam set dose are included as the last dose statistics prior to the plan dose statistics. for such a report template, all reports for multiple beam set plans would always be affected., the user must be aware of information to avoid incorrect assessment of treatment plan dose levels. i.E inspect all report templates that are intended to be used for plans with multiple beam sets. make sure that "poi dose statistics (plan)" is included immediately before "roi dose statistics [plan dose]" in the report content area., this issue will be resolved in the next version of raystation, scheduled for market release nov 2016.
  • Action
    Manufacturer to issue advice regarding use

Device

RaySearch RayStation Treatment Planning System
  • Modèle / numéro de série
    Model: , Affected: , Software version: 5.0.0.37, 5.0.1.11 and 5.0.2.35
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB