Events

Retiro De Equipo (Recall) de iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software)

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-2015-RN-00616-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-08
  • 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-2015-RN-00616-1
  • 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 automatic monitor units (mu) calculation (normalisation) might be incorrect in the brainlab iplan rt dose versions 4.0 and 4.1 if all of the following conditions are met: - several ptvs are planned in the treatment plan, and - at least one treatment group or treatment element is locked to prevent further modification, and - for any ptv with a locked treatment group or with at least one locked treatment element assigned the dose at the 50% volume constraint point deviates more than 5% from the actual dose at 50% volume.If the mu calculation is refreshed, the software will always normalise the dose of the ptvs, which do not have a locked treatment group or treatment element assigned, to the 50% volume constraint point. other constraint points for the ptvs will be disregarded even if a constraint point is set “hard constraint” and therefore the intended prescription will not be automatically fulfilled for ptvs without a locked treatment group or locked treatment element.
  • Acción
    Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers starting January 2016 to schedule the update. This action has been closed-out on 12/08/2016.

Device

iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Soft...
  • Modelo / Serial
    iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software)ARTG Number: 121114
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd