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
    19938
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-05-06
  • 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
    Note: series date parameter is optional and not found on all systems. mr misalignment in cone planning could be consistently encountered on any datasets where mr data has an empty (0008 0021) series date dicom element. while the mr image could be correctly fused with a corresponding ct dataset fusion results will be incorrectly loaded into fastplan's cone planning if an empty series date data field is encountered. no warning or error message is produced. any resulting large misalignment should be obvious if the blended ct-mr view is selected since the isocenter will be misplaced on the 3d view and trace contour views. in the worst case scenario however if you use the default mr- only view settings perform planning on mr only and do not notice isocenter misplacement on the 3d view or on contour tracing slides this could lead to a significant mis-alignment of the plan.

Device

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

Manufacturer

VARIAN MEDICAL SYSTEMS INC.