Events

Retiro De Equipo (Recall) de Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator 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 Elekta 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-00019-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-13
  • 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-00019-1
  • 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
    During the treatment table, gantry and collimator calibration procedures, it is possible to type the incorrect values or invert a value. if the user does not do the quality assurance (qa) procedures after the calibration, it is possible that the user will not find the error made during the calibration. this could result in delivering the treatment with the patient in the incorrect position resulting in clinical mistreatment.
  • Acción
    Users are asked to undertake QA procedures in accordance with the instructions for use (IFU) for Integrity, Precise Table and X-ray Volume Imager (XVI). Users will be informed of the mandatory software upgrade upon its release (expected early 2014) which will mitigate the issue. This action has been closed-out on 02/02/2016.

Device

Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator system)
  • Modelo / Serial
    Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator system)ARTG Number: 111760
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DHTGA