Events

Retiro De Equipo (Recall) de Device Recall Oncentra External Beam Treatment Planning Software

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Elekta, Inc..

¿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
    72869
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0604-2016
  • Fecha de inicio del evento
    2015-12-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142386
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System,planning,radiation therapy treatment - Product Code MUJ
  • Causa
    When using the option "tumor overlap fraction" in vmat planning it has been observed that in rare cases the system does include an organ at risk as target volume. this could result in open mlc, and open jaws in areas away from the target volume.
  • Acción
    Elekta sent an Important Field Safety Notice 806-01-ETP-001 to all affected customers on December 18, 2015. The notice informs users of the issue and that should the issue occur it could result in overdosage of organs at risk outside the intended treatment volume. Users are strongly advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient. To prevent the issue from occurring, the workaround is to not use the Tumor Overlap Fraction for VMAT planning.and not to use the Tumor Overlap Fraction for VMAT planning. The issue will be solved in Oncentra External Beam version 4.5.2. The notice included an acknowledgement form which is to be returned to Elekta. For questions contact your local Elekta representative.

Device

Device Recall Oncentra External Beam Treatment Planning Software
  • Modelo / Serial
    Versions 3.3 and higher
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of CA, NY, PA, and the countries of Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden and United Kingdom.
  • Descripción del producto
    Oncentra External Beam - VMAT - Radiation therapy planning system || Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA