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
    104970
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-08-21
  • 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
    Eclipse treatment planning system where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client worstation is not synchronized with the database / system server. when the eclipse client workstation clock is running behind the clock on the database/ system server it is possible that a change to the assigned hu value for a structure does not invalidate the density image stored in the cache and for the subsequent dose and monitor unit [mu] calculation to be based on the outdated hu assignment. the resultant mus may be higher or lower than expecteddependent on the specific hu assignments. treatment of the patient using these values can therefore lead to under - or over dose.

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
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.