Retiro De Equipo (Recall) de ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient positioning system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Brainlab Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    When using multiple isocenters (multiple radiation treatment targets) within a single plan, if a specific workflow is used and certain variables relating the software timing and user interaction are met, exactrac v6.0.3 might position the patient to an unintended isocenter position.
  • Acción
    Brainlab is requesting end users to avoid using treatment plans with multiple isocenters. If a plan with multiple isocenters cannot be avoided always close the patient ExacTrac after treatment of one isocenter is finished and reload the patient plan before selecting the next isocenter. Also, make sure to always select only one isocenter of the plan in ExacTrac in between opening and closing the patient. Brainlab will release a software update to correct the issue. Thia action has been closed-out on 28/01/2016