Events

Retiro De Equipo (Recall) de Monaco RTP System (Radiation Treatment Planning System Software)All releases of Monaco

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Elekta 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
    Recall
  • ID del evento
    RC-2013-RN-00556-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-31
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00556-1
  • 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
    Patients can be scanned either head first or feet first and these cts imported into monaco for radiation treatment planning. the monaco ct sim workflow gives an option to prepare a feet first plan, but monaco imrt workflow does not. although a patient can be scanned feet first and these feet first cts imported into monaco, the user could incorrectly assume that the intensity-modulated radiation therapy (imrt) plan is feet first as well. when the patient is treated, they could be incorrectly positioned in the feet first position which will not match the plan. if the patient is positioned for treatment in the feet first position, the imrt treatment plan will not match what is delivered, potentially resulting in a significant beam geometry error.
  • Acción
    Elekta has updated the Monaco User Guide and on-line help to explicitly indicate that Monaco does not support feet first IMRT planning. The updated information is being provided to end users with the recall correspondence.

Device

Monaco RTP System (Radiation Treatment Planning System Software)All releases of Monaco
  • Modelo / Serial
    Monaco RTP System (Radiation Treatment Planning System Software)All releases of MonacoARTG Number:186856
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DHTGA