Events

Retiro De Equipo (Recall) de Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Version 11 with PBC 11.0.21, 11.0.30

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia 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-00105-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-04
  • 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-00105-1
  • 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
    The final calculated dose of dose dynamic fields will be incorrect when both conditions occur:1. the pencil beam convolution [pbc] 11 algorithm license feature is used,2. either the energy and/or the treatment unit of a dose dynamic field, differs fromthat of the first created treatment field in the plan.Under these conditions, the final dose calculation will determine the mu to dose calibration (mugy10) factor and the applicable dose rate table value (csbf coefficient) using the energy of the first treatment field (in the order of creation) for all dose dynamic fields, regardless of the actual field energy.
  • Acción
    Varian Medical Systems is requesting users to not use the Pencil Beam Convolution (PBC) 11 algorithm for dose dynamic plans. It is recommended that dynamic MLC plans are calculated with the AAA or Acuros XB algorithm. PBC versions prior to version 11 can still be used. Varian recommends a review of treated patient plans where the PBC 11 algorithm was used for the calculation of dose dynamic plans. A technical correction is under development and will be implemented once complete.

Device

Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Versi...

Manufacturer

Varian Medical Systems Australasia Pty Ltd