Events

Retiro De Equipo (Recall) de OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM

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
    143971
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-07
  • 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 the ct localization module of the fastplan treatment planning system. if the module reports a significant different in tilt or spin on a slice (compared to the average of all slices) and the user elects to "discard" that slice an incorrect calculation of the isocenter location may result. the calculated ct localization volume can be incorrect when the "discard option is selected after a detection of a significant difference in tilt or spin for a particular slice. if this issue goes undetected the reported coordinates of the isocenter will be incorrect and a mistreatment could result.

Device

OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM
  • Modelo / Serial
    Model Catalog: 9701505A (Lot serial: HZ37010)
  • Descripción del producto
    Optical Guidance Platform - FastPlan System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.