Events

Retiro De Equipo (Recall) de RaySearch RayStation Treatment Planning System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por RaySearch Laboratories AB.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20245
  • Fecha de inicio del evento
    2016-06-07
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Causa
    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.
  • Acción
    Manufacturer to issue advice regarding use

Device

RaySearch RayStation Treatment Planning System
  • Modelo / Serial
    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