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 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
    75863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0734-2017
  • Fecha de inicio del evento
    2016-11-22
  • Fecha de publicación del evento
    2016-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151477
  • 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
    Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. this issue is limited to certain cyberknife¿ systems with software version 1 0.6.
  • Acción
    Accuray sent an Urgent Safety Advisory Notification letter dated November 22, 2016, to all affected customers. Letters alerted users to the issue and the sequence of events necessary for it to occur. Accuray reps will visit all sites to perform a software upgrade to correct the issue. For more information or any questions about this notification, please contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support. For further questions, please call (408) 716-4600.

Device

Device Recall CyberKnife Robotic Radiosurgery System
  • Modelo / Serial
    Catalog/Part Number: 54000 manufacturing or serial number of UDI: M658053301 0; Serial numbers:  C0330 C0334 C0336 C0338 C0342 C0344 C0348 C0349 C0351 C0358 C0359 C0360 C0361 C0363 C0364 C0366 C0367 C0370 C0372 C0376 C0387 C0389 C0390 C0391 C0393 C0394 C0395 C0396 C0397 C0398 C0400 C0402 C0404 C0406 C0407 C0408 C0409 C0410 C0413 C0414
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey
  • Descripción del producto
    CyberKnife Robotic Radiosurgery System using software version 10.6; || Catalog/Part Number: 54000 || UDI: M658053301 0 || Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for 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