Events

Retiro De Equipo (Recall) de Raystation RaySearch therapy 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
    16240
  • Fecha de inicio del evento
    2014-02-17
  • 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
    The manufacturer advises there is an issue with the dose calculation in specific versions of the raystation software. the error appears in some situations for bolus/external/fixation/support structures that are outside the image stack but covered by the dose grid. when converted to dose grid structures they are cut off at the image stack boundaries (first and last slice) in the inferior-superior direction. for a bolus/external/fixation/support structure this means that the part outside the image stack does not contribute to the density distribution and the dose calculation will be affected. only structures before the first slice or after the last slice are affected, not structures outside the image stack in the anterior/posterior/left/right direction.
  • Acción
    Software to be upgraded

Device

Raystation RaySearch therapy treatment planning system
  • Modelo / Serial
    Model: , Affected: , Software version: Versions: 2.0, 2.5, 3.0, 3.5, 4.0
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB