Events

Retiro De Equipo (Recall) de RaySearch 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
    20610
  • Fecha de inicio del evento
    2016-09-06
  • 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
    Two issues have been identified with the dose calculation when using a region of interest (roi) of type fixation or support with material override within the patient outline in raystation models., 1. when an roi with material override overlaps a fixation or support roi, the material used for dose calculation in the overlapping region may not be as intended., 2. when a support or fixation roi overlaps the patient outline (external roi) in a dose grid voxel along the outer surface of the patient outline, the density used for dose calculation in that voxel may not be as intended.
  • Acción
    Instructions for use to be updated

Device

RaySearch Radiation Therapy Treatment Planning System
  • Modelo / Serial
    Model: 2.5, 3.0, 4.0, 4,5, 5.0 and 4.3 and InverseArc 1.0, Affected:
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB