Events

Retiro De Equipo (Recall) de RaySearch RayStation Radiation therapy treatment planning system 4.0

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
    16598
  • Fecha de inicio del evento
    2014-04-30
  • 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
    There is a potential problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi (region of interest) can be wrong. this affects all dose-volume properties for such rois, including dvh (dose-volume histogram), dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution.
  • Acción
    Software to be upgraded

Device

RaySearch RayStation Radiation therapy treatment planning system 4.0

Manufacturer

RaySearch Laboratories AB