Events

Retiro De Equipo (Recall) de Device Recall Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22

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 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
    50143
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0855-2009
  • Fecha de inicio del evento
    2008-10-02
  • Fecha de publicación del evento
    2009-01-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74812
  • 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
    Radiation Therapy Treatment Planning System - Product Code MUJ
  • Causa
    When using the multiple static segment option, the device may alter dose delivery.
  • Acción
    An Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps on October 2, 2008. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm recommends that customers DO NOT USE the Multiple Static Segment (MSS) option in Varian Leaf Motion Calculator version 8.2.22. The firm also recommends setting the default delivery method for Varian Leaf Motion Calculator to Sliding Window. When using Eclipse 8.5, always follow the Safety Instructions found in chapter 2 of "Eclipse External Beam Planning Instruction for Use", P/N B501357R01A, March 2008. If customers believe a patient treatment has been affected by this issue, they should notify a Varian Service or Support person as soon as possible.

Device

Device Recall Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8....
  • Modelo / Serial
    Model number H48, serial numbers H480016, H480051, H480052, H480053, H480054, H480055, H480107, H480133, H480293, H480346, H480347, H480472, H480652, H480920, H481467, H481510, H481639, H481724, H481807, H481815, H481816, H481912, H481913, H481914, H481915, H482194, H482195, H482289, H482793, H482807, H483204, H483407, H484367, H484635, H484636, H484637, H484638, H484781, H484864, H485100, H485125, H485244, H485346, H485466, H485729, H486858, H486859, H486860, H486861, H486946, H486947, H486948, H487190, H487212, H487414, H487580, H487581, H487623, H487640, H487641, H487642, H487700, and H487757.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.
  • Descripción del producto
    Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. || Indicated for planning proton treatment of neoplasms of the eye.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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