Events

Retiro De Equipo (Recall) de CyberKnife Robotic Radiosurgery System with IRIS Variable Aperture Collimator.

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
    69645
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0218-2015
  • Fecha de inicio del evento
    2014-10-31
  • Fecha de publicación del evento
    2014-11-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131252
  • 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
    Software upgrade to correct potential safety issue related to cyberknife system that occurs when upgrading the treatment delivery software for the first generation iris variable aperture collimator.
  • Acción
    Accuray sent an Urgent Safety Advisory Notification letter dated October 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the radiaiton field size (beam width) for each Iris setting to ensure that it matches the beam commissioning data in the MultiPlan System to within the stated tolerance of 0.2 mm. Customers with questions were instructed to contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solutions Center at www.accuray.com or call North America: +1.877.668.8667, Europe: +800.4141.9595, Hong Kong +852.2247.8688, Japan +81.3.6269.9556. For questions regarding this recall call 408-716-4600.

Device

CyberKnife Robotic Radiosurgery System with IRIS Variable Aperture Collimator.
  • Modelo / Serial
    Catalog/Part number 054000-0001; Serial numbers: C0141 C0182 C0225 C0256 C0137 C0112 C0244 C0210 C0160 C0208 C0118 C0090 C0207 C0181 C0034 C0047 C0197 C0174 C0101 C0186 C0178 Serial # C0198 C0214 C0059 C0172 C0068 C0057 C0263 C0092 C0199 C0151 C0179 C0226 C0158 C0131 C0144 C0223 C0071 C0094 C0183 C0143 Serial # C0192 C0055 C0072 C0061 C0134 C0177 C0247 International Sites Serial # C0175 C0189 C0191 C0215 C0227 C0187 C0242 C0185 C0218 C0237 C0240 C0265 C0268 C0251 C0235 C0229 C0212 C0239 Serial # C0043 C0211 C0255 C0270 C0176 C0093 C0234 C0221 C0249 C0232 C0180 C0238 C0231 C0202 C0230 C0264 C0266.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, MS, FL, AZ, DC, TX, CO, CT, IL, WI, RI, NV, OK, MA, AL, NY, MO, NC, TN, PA, DE, NJ, MI, IN, KS, OH. Foreign distribution to Turkey, Switzerland, Spain, Saudi Arabia, Russia, Poland, Mexico and Korea, Italy, India, Greece, Germany, France, England, Canada, and Belgium.
  • Descripción del producto
    CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. || The CyberKnife 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