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
    27320
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-16
  • 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
    An anomaly has been identified with varian eclipse treatment planning system and aria radiation oncology (rt chart application) where adding a reference point in aria rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse. a reference point added in aria rt chart does not have a location and is sometimes referred to as a "dose prescription volume" or dpv. if a reference point without location or dpv is added in aria rt chart and the field dose contribution of the reference point is edited this may cause the dose per fraction and total prescribed dose of an unapproved treatment plan in eclipse to change. this anomaly can occur when there is plan normalization such that the total done and the total dose at primary have different values.

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.