Events

Retiro De Equipo (Recall) de 4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia 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-00947-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-29
  • 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-00947-1
  • 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
    Varian received two reports from customers with c-series linear accelerators (linac) used with varian’s barcode conical collimator verification system (bccv) and brainlab’s exactrac patient positioning system where the user was able to clear the interlock for bccv, imposed by the 4ditc, from the exactrac console. in both reported cases, the user was employing a c-series he linac with 4ditc and both exactrac and bccv. the user was authorising the exactrac to the linac 4ditc. successive signals were sent from the exactrac to the 4ditc. the first signal cleared the exactrac interlock as intended. the exactrac console requested user confirmation of the second command to authorise. the user responded affirmatively. the signal was sent to the 4ditc, and the linac interlock associated with bccv was released. in such a situation, it may be possible to irradiate the patient using a cone other than what is specified by the treatment plan because the bccv verification was not completed.
  • Acción
    Varian is reminding users of the correct procedures using auxiliary devices requiring the ADI interface and is providing recommended verification steps when carrying out treatment i.e., stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). A permanent fix has been developed and a Varian representative will schedule the installation. This action has been closed-out on 12/08/2016.

Device

4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery ...
  • Modelo / Serial
    4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)Product code: H51Serial Numbers: H514278, H514544, H515102, H51B568, H513894, H515619 & H51B100ARTG Number: 116839
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd