Events

Retiro De Equipo (Recall) de Device Recall Elekta Precise Linear Accelerator 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 Elekta, 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
    70279
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1088-2015
  • Fecha de inicio del evento
    2015-01-07
  • Fecha de publicación del evento
    2015-02-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132771
  • 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
    Elekta has identified a batch of securing bolts that fix the gantry counter frame weight stack may fail.
  • Acción
    Elekta sent an Urgent Important Field Safety Notice on January 7, 2015, to all affected customers. Elekta recommended that customers replace the M20 x 50 MM bolts marked 'OF' on the gantry counterbalance frame immediately. The digital linear accelerator must not be used until these 'OF' bolts are replaced. Elekta recommended that customers put the machine in a parked position at 0, and attach the gantry locking straps. A Modification kit will be available as soon as possible which contains the correct bolts. Customers were instructed to complete the Important Field Safety Notice Acknowledgement form and return to their local Elekta Office or Representative. Customers with questions were instructed to contact their local Elekta representative. For questions regarding this recall call 404-993-5886.

Device

Device Recall Elekta Precise Linear Accelerator System
  • Modelo / Serial
    153602, 153538, 153561, 153569, 153532, 153556, 153566, 153563, 153564, 153589, 153530, 153531, 153562, 153584, 153615, 153534, 153534, 153535, 153563, 153542, 153542, 153548, 153548, 153558, 153578, 153595, 153699, 153630, 153728, 153680, 153712. 153717, 153723, 153734, 153702, 153715, 153684, 153710, 153577, 153725, 153726, 153691, 153696, 153713, 153724, 153727
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan and Ukraine.
  • Descripción del producto
    Precise Digital Accelerator || Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA