Events

Retiro De Equipo (Recall) de Device Recall CyberKnife 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 Accuray 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
    54535
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1008-2011
  • Fecha de inicio del evento
    2009-12-29
  • Fecha de publicación del evento
    2011-02-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88658
  • 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
    If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. a plan may be created and saved, thus creating the risk of mistreatment.
  • Acción
    The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated December 29, 2009, to all customers. The letter described the product, problem, and action to be taken by the customers. The customers were instructed to verify correctness of the CT number to relative electron density and Mass Density Calibration curves. Note: A patch is being developed to address this issue. Accuray Customer Support will contact the customers regarding further resolution. If you have any questions or concerns regarding this issue, please contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non USA) or by email: customersupport@accuray.com.

Device

Device Recall CyberKnife Treatment Planning System
  • Modelo / Serial
    All systems with multiplan tratment planning system software version 3.5
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA and countries including: Canada, Turkey, India, Italy, France, the Netherlands, the UK, India, Spain, Greece, Saudi Arabia, Switzerland, Germany and China.
  • Descripción del producto
    CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 || Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Accuray Inc

Manufacturer

Accuray Inc
  • Dirección del fabricante
    Accuray Inc, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Source
    USFDA