Retiro De Equipo (Recall) de Brianlab iPlan RT Image (versions below v.4.1.2) / iPlan RT and BrainSCAN (discontinued in 2002) (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
  • 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
    The only image sets that are supported by the brainlab radiation treatment planning software even when containing varying calibrations of pixel values in between image slices are ct image sets & pet image sets normalised to suv with suv also loaded in and displayed by the brainlab swif such an unsupported image set is used the same pixel value calibration as contained in the middle image slice of the set to all slices is applied. in a pet image set uniform calibrated pixels might then have a different activity value, thus displayed with a different brightness and colour, compared to the image slices as displayed by the scanner using varying calibrations. if this effect occurs when using an unsupported image set, it can be misleading to the user during treatment planning and result in an incorrect definition of vols of interest in the planning s/w. the objects created for these vols of interest might differ in location or dimension from the actual desired definition of the structure.
  • Acción
    Brainlab will provide a software solution with the corresponding new feature for affected iPlan RT / iPlan RT Image customers to prevent the described scenario from occurring. In the interim, customers are advised to: - Except for CT and PET used with SUV, only load and use image sets in iPlan RT / iPlan RT Imagethat have the same pixel value calibration for all images of the set. - Before using image datasets loaded into the Brainlab Radiation Treatment Planning Software, always compare the images displayed in the Brainlab application to the images as displayed by the imaging device (scanner). Delete and do not use the image sets within iPlan RT in case any deviation is detected and contact Brainlab support. Brainlab will not provide a software update for BrainSCAN. Brainlab strongly recommends customers still using BrainSCAN clinically to phase out the use of this software as soon as possible but in no event later than January 2016. This action has been closed-out on 02/12/2016.


  • Modelo / Serial
    Brianlab iPlan RT Image (versions below v.4.1.2) / iPlan RT and BrainSCAN (discontinued in 2002) (Radiation therapy treatment planning system)ARTG Number: 121114
  • Manufacturer