Events

Retiro De Equipo (Recall) de Brainlab Patient Data Manager

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-2014-RN-00784-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-14
  • 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-2014-RN-00784-1
  • 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
    Brainlab has identified two potential problems when loading image data that consists of non-square pixels with pdm 2.0. 1- display of image data: when loading non-square pixel image data with pdm 2.0, the data set is not correctly transferred and displayed in the corresponding brainlab navigation or planning software. 2- dose calculation: it has been determined that non-square pixel data is not suitable for dose calculation with the current brainlab iplan rt systems.
  • Acción
    End users are advised to not load image data sets with non-square pixels if Brainlab Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2) is installed at your hospital. Brainlab will provide a software update to affected customers to correct this issue. This action has been closed-out on 01/03/2016.

Device

Brainlab Patient Data Manager

Manufacturer

Brainlab Australia Pty Ltd