Events

Retiro De Equipo (Recall) de MONACO

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ELEKTA 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
    144084
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-16
  • 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
    In a specific workflow where contours are edited and then the contour is deleted on some slices and saved in the same session it is possible that the deleted contours are still present which would not be the intent of the planner. if the patient is not saved and recalled in a subsequently created plan the bev will show the contours as still present while the transverse sagittal and coronal views will show the contours as deleted. the total volume of the structure reported in the dvh and the structure control will not match. if the study set is saved and reopened before plan creation the total volume of the structure reported in the dvh and the structure control will be corrected. a similar workflow could trigger the defect if contour deletions and edits are performed while a plan is loaded.

Device

MONACO
  • Modelo / Serial
    Model Catalog: MONACO (Lot serial: VERSION 3.1 AND HIGHER)
  • Descripción del producto
    MONACO
  • Manufacturer
    ELEKTA INC.

Manufacturer

ELEKTA INC.
  • Dirección del fabricante
    ATLANTA
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    HC