Devices

Device Recall iGUIDE System

  • Modelo / Serial
    Software iGUIDE 2.1 and 2.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
  • Descripción del producto
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
  • Manufacturer
    Elekta, Inc.
  • 1 Event

Fabricante

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

Dispositivo con un nombre similar

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Device Recall iGUIDE System
  • Modelo / Serial
    Software Versions 2.0.0, 2.0.1 and 2.0.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam
  • Descripción del producto
    iGUIDE System || Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
  • Manufacturer
    Elekta, Inc.