Events

Retiro De Equipo (Recall) de Varian brand Eclipse Treatment Planning System

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 Varian Medical Systems, Inc. Oncology Systems.

¿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
    63093
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2462-2012
  • Fecha de inicio del evento
    2012-08-17
  • Fecha de publicación del evento
    2012-09-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112531
  • 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
    Varian has identified an anomaly with the eclipse treatment planning where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client workstation is not synchronized with the database/system server. treatment of the patient using these values can therefore lead to under or over-dose.
  • Acción
    VARIAN Medical Systems sent an Urgent Medical Device Correction Urgent Field Safety Notice on August 17, 2012, to all affected customers with a description of the problem and user corrective action steps. Customers were instructed to ensure that the workstation clock be synchronized with the DatabaseSystem server clock. Customers were also instructed to contact Varian service for assistance with time synchronization if required. Customers were to complete the attached Proof of Notification Form once they have read the document and return it to Varian Medical Systems. For questions customers should call the following numbers: USA and Canada 1-888-827-4265. Europe +41 41 749 8844. For questions regarding this recall call 650-424-5731.

Device

Varian brand Eclipse Treatment Planning System
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally. . .
  • Descripción del producto
    Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 || Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA