Events

Retiro De Equipo (Recall) de MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)

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-2017-RN-00836-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-04
  • 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-2017-RN-00836-1
  • 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 machine characterization (mac) file is instrumental to the correct operation of mosaiq and your elekta linac. elekta has become aware of the potential for incorrect characterization of couch values, which will lead to incorrect table movements when using couch move assistant (cma). if the mac file is set up incorrectly it is possible that table shifts can be made in the wrong direction.
  • Acción
    Elekta is requesting the following: 1. If you are using the Couch Move Assistant (CMA) feature in MOSAIQ , run the verification test(s) given in the Customer Letter to ensure that your table is operating correctly; 2. Users should only run the tests applicable to your clinical workflows on all of your Elekta linacs that are configured for CMA; 3. If the test(s) pass successfully, sign the Acknowledgement form and return the form to Elekta; and 4. If the test(s) fail contact your local Elekta Care Support Centre for assistance.

Device

MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information sys...
  • Modelo / Serial
    MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)Elekta Reference Number: FCA-IMS-0024ARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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