Events

Retiro De Equipo (Recall) de Device Recall CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.

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 Incorporated.

¿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
    60437
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0382-2012
  • Fecha de inicio del evento
    2011-11-07
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105406
  • 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
    User facility reported an anomaly where inhale and exhale ct pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
  • Acción
    Accuray sent a Urgent Medical Device Correction letter dated November 7, 2011, via Federal Express to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The information provided in this letter will be incorporated in user manuals shipped with the CyberKnife system. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at 1. (877) 668-8667 ( USA) 1. (408) 716-4700 ( non USA )

Device

Device Recall CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.
  • Modelo / Serial
    Model number: PN 032384
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA ( nationwide ) including the states of FL, TN, IL, NJ, CO, PA, MD, CA, MS, MN, SC, WA, OK, GA, AZ, and TX., and the countries of France and United Kingdom.
  • Descripción del producto
    CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. || The CyberKnife treatment is indicated for the 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 Incorporated

Manufacturer

Accuray Incorporated
  • Dirección del fabricante
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Source
    USFDA