Events

Retiro De Equipo (Recall) de Device Recall 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
    52643
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1810-2009
  • Fecha de inicio del evento
    2009-06-22
  • Fecha de publicación del evento
    2009-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83540
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Targeting accuracy out of specification, error alert does not render the system down, which may result in mistreatment in the wrong area.
  • Acción
    Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue. For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.

Device

Device Recall CyberKnife Robotic Radiosurgery System
  • Modelo / Serial
    All system Serial Numbers C128 and higher with 2005 edition Robot Controller.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.
  • Descripción del producto
    CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. || Indicated for treatment for 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