Events

Retiro De Equipo (Recall) de Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning 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 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-00140-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-12
  • 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-00140-1
  • 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
    When an arc based plan is created, the beam will have a default "rotation_start" angle. if the start angle for the arc is edited and then the plan delivery type is changed to a non-arc beam, the rotation start angle does not update as it should. the result is that the beam is displayed at the 'gantry' angle, but the dose is calculated at the "rotation_start" angle. if the patient is treated at this beam gantry angle, the patient will not receive the dose that the treatment planning system has calculated and displayed.
  • Acción
    The problem was introduced in Monaco Release 3.20.00. The issue is resolved in the Monaco 3.20.02 Patch Release and in Monaco Release 3.30.00. Elekta is asking customers to download software fix from its website.

Device

Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)
  • Modelo / Serial
    Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)ARTG Number: 186856
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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