Events

Retiro De Equipo (Recall) de ExacTrac 5.5.5 (Image guided radiation therapy patient positioning 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-2014-RN-00439-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-14
  • 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-00439-1
  • 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
    When using a specific plan update workflow in combination with a non-brainlab treatment planning system (tps), there is a possibility in exactrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. if the anomaly occurs, the information displayed by exactrac under “external name” and “dicom patient coordinates” might not be correctly related to the information simultaneously displayed within the “image set reconstruction” picture and under “brainlab coordinates”. such a display of inconsistent positioning information might mislead the user when selecting a treatment plan / isocenter in exactrac for patient positioning. if not detected by the user, this might result in a patient and treatment target position at the linear accelerator (linac) that is different than intended. as a consequence the treatment dose might be delivered to a region different from the intended target region.
  • Acción
    Customers are advised to continue to always follow the instructions and warnings as described in the user guide. Brainlab also recommends: - To enter meaningful plan comments during treatment planning. When selecting a plan in ExacTrac, before proceeding with patient positioning, always review this comment within ExacTrac together with the plan date. - To always verify the correct isocenter position inside the “Image Set Reconstruction” picture before proceeding with patient positioning. Brainlab will provide a software update to the affected customers which will resolve the issues identified.

Device

ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)
  • Modelo / Serial
    ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)Product Version Number: ExacTrac 5.5.5ARTG Number: 121226
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd