Events

Retiro De Equipo (Recall) de RaySearch RayStation - Radiation 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
    15008
  • Fecha de inicio del evento
    2013-07-17
  • 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
    As issue has been identified in the raystaion 3.0 and 3.5 dose volume statistics calculation. under certain conditions resampling of regions of interest (roi) geometries to the dose grid representations is not correctly calculated and an additional voxel layer is added incorrectly on the superior side of each roi., the problem is pronounced for very small rois, leading to a possible over estimation of the dose maximum or a possible under estimation of the dose minimum, thus always erring on the safe side. worst-case scenario is delivering less dose than optimal to target organs.
  • Acción
    Manufacturer to issue advice regarding use

Device

RaySearch RayStation - Radiation therapy treatment planning system

Manufacturer

RaySearch Laboratories AB