Events

Retiro De Equipo (Recall) de ARIA Radiation Oncology System (information system), versions: 11.0 below 11.0.55, Build 11.02.28 and 11.0.34

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-2012-RN-01235-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-12-07
  • 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-2012-RN-01235-1
  • 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
    An anomaly has been identified during internal investigation with the aria oncology information system version 11 dicom import/export functionality where a 360 degree arc field may convert to static field during dicom export or import.
  • Acción
    Varian is providing work around instructions to users and is developing a permanent solution.

Device

ARIA Radiation Oncology System (information system), versions: 11.0 below 11.0.55, Build 11.02.28...
  • Modelo / Serial
    ARIA Radiation Oncology System (information system), versions: 11.0 below 11.0.55, Build 11.02.28 and 11.0.34Product code: HITAffected ARIA versions: 11.0 below 11.0.55, Build 11.02.28 and 11.0.34Affected serial numbers: HIT0339M, HIT0339R1 & HIT4909ARTG number: 132638
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd