Events

Retiro De Equipo (Recall) de Monaco RTP System (Radiation Treatment Planning System Software)

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-2013-RN-00708-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-16
  • 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-2013-RN-00708-1
  • 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
    This issue affects monaco releases that have been upgraded to 3.20.00 (from 3.10.00) and 3.30.00 (from 3.20.00) and a sample couch parameter file has been edited and saved prior to the upgrade. if the sample couch parameter files are edited (post upgrade), the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. if these changes are saved under the original name, when a software upgrade is loaded, the modified couch densities in these sample files will be overwritten with the default value of 1.000.
  • Acción
    Elekta is providing work around instructions for users to follow as an interim measure, Elekta is currently working on a preventative action, and will provide further information once this has been determined.

Device

Monaco RTP System (Radiation Treatment Planning System Software)
  • Modelo / Serial
    Monaco RTP System (Radiation Treatment Planning System Software) Release 3.20.00 and 3.30.00 upgraded from 3.10.00 or 3.20.00 ARTG Number: 186856
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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