Events

Retiro De Equipo (Recall) de iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy 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 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
    Recall
  • ID del evento
    RC-2013-RN-00339-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-19
  • 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-00339-1
  • 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
    Iplan rt dose version 4.0 and 4.1 might not correctly refresh the dose calculation after certain mlc shape modifications if all of the following conditions are met:- the modifications are performed for a dynamic conformal arc, and- the jaw positions are defined manually, and- the dose display (e.G. isodose lines) is turned on, or if the dose has already been calculated and the dose display is turned on again after the mlc shape was modified. the effect may occur for the following modifications of the mlc shape: - the mlc margin of the arc is modified- the mlc shape is modified in the beam’s eye view (bev) in a way that also changes the mlc shapes of neighbouring segments of the arc1- the leaf adaption is modified (inline/average/outline)- the modified mlc shapes in the bev are resetthe dose calculation is not refreshed in the physician’s review and physicist’s verification tasks or when generating the printout or exporting the plan.
  • Acción
    Brainlab is providing work around instructions and is developing a software update to permanently correct the problem.

Device

iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planni...
  • Modelo / Serial
    iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system)ARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd