Events

Retiro De Equipo (Recall) de Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10

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-00920-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-07
  • 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-00920-1
  • 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
    When the clock on the eclipse client workstation is running behind the clock on the database/system server, it is possible that a change to the assigned hu value for a structure dose not invalidate the density image stored in the cache, and for the subsequent dose and monitor unit calculation to be based on the outdated hu assignment. the resultants mus may be higher or lower than expected. treatment of the patient using these values can lead to under or overdosing.
  • Acción
    Varian is providing users with work around instructions and will be providing a technical correction to permanently correct the issue when available.

Device

Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 a...
  • Modelo / Serial
    Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10Product Code: H48Multiple serial numbers affectedARTG Number: 119983
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd