Events

Retiro De Equipo (Recall) de ECLIPSE TPS V8.8

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VARIAN MEDICAL SYSTEMS INC..

¿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
    79362
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-04-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The energy shown or selected by the treatment planner in the 'fields' tab of the external beam planning (ebp) and in the 'general' tab of field properties may differ from the value actually used for dose calculation. caused by incorrect handling of the energy mode object within the memory cache system used by eclipse external beam planning version 10. when the user changes field energy the memory cache anomaly may result in use of previously selected field energy instead of intended field energy. this cache memory issue may arise when switching between software applications (such as between external beam planning and rt chart) when using multiple sessions or when switching between patients in a single session of ebp in eclipse.

Device

ECLIPSE TPS V8.8
  • Modelo / Serial
    Model Catalog: 100042024 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: 100042024 (Lot serial: CONTACT MANUFACTURER.)
  • Descripción del producto
    Eclipse Treatment Planning System V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.