Events

Retiro De Equipo (Recall) de CyberKnife Robotic Radiosurgery 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
    50208
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0856-2009
  • Fecha de inicio del evento
    2008-10-30
  • Fecha de publicación del evento
    2009-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74987
  • 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 Device - Product Code JAI
  • Causa
    Product may not be tensioned properly, potentially causing unexpected rotation or descent.
  • Acción
    All affected sites were notified of the potential problem via Customer Advisory Notice dated 30 October 2008. The letter states required actions that the customer should follow at the beginning of each treatment day. The tension of the belt drive and the support bolts in question will be inspected by Accuray Field Service personnel at the affected facilities. In addition, the preventive maintenance procedure will be updated to include regular inspection and replacement of the belt-drive. Any questions or concerns regarding this issue should be directed to Accuray Customer Support at 1-877-668-8667 or 1-408-716-4700 or customersupport@accuray.com.

Device

CyberKnife Robotic Radiosurgery System
  • Modelo / Serial
    Model number 025007, system numbers C0158, C0078, C0141, C0160, C0128, C0178, C0179, C0152, C0110, C0113, C0130, C0060, and C0125.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of France and Turkey.
  • Descripción del producto
    RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA || The CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. || The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
  • Manufacturer
    Accuray Inc

Manufacturer

Accuray Inc
  • Dirección del fabricante
    Accuray Inc, 1310 Chesapeake Ter, Sunnyvale CA 94089
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Source
    USFDA