Events

Retiro De Equipo (Recall) de iPlan RT, iPlan RT Dose and BrainSCANAll Software versions

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-2016-RN-01641-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-12-23
  • 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-2016-RN-01641-1
  • 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 an issue where there is the possibility of a potential inaccurate dose calculation for small mlc-shaped fields when using the pencil beam algorithm. the pencil beam algorithm refers to beam data which is acquired by performing dose measurements for mlc fields at predefined field sizes and which are stored using the iplan rt physics administration / brainscan beam profile editor. due to an inaccurate implementation in the brainlab radiation treatment planning software, the interpolation between two measured values is less accurate a) the smaller the field and;b) the further away the equivalent field size is from the measured value. for certain treatment setups, this leads to the effect that an insufficient amount of monitor units (mu) is calculated and that consequently the delivered dose is lower than the planned dose. for clarity, the delivered dose does not exceed the planned dose due to the described issue.
  • Acción
    As a workaround, to reduce the described dose deviation to less than 2% using the Pencil Beam algorithm in iPlan RT 4.5.x Brainlab recommends to modify the machine profile following the instructions outlined in the Appendix provided. For all Brainlab treatment planning systems, as recommended by Brainlab, perform proper pre-treatment quality assurance for every treatment plan. Independent calculation of the dose using 3rd party QA Software or dose measurements inside a phantom is suitable to judge the accuracy of the dose calculation. Refer to the Brainlab Physics Technical Reference Guide for details.

Device

iPlan RT, iPlan RT Dose and BrainSCANAll Software versions
  • Modelo / Serial
    iPlan RT, iPlan RT Dose and BrainSCANAll Software versionsARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd