Device Recall CyberKnife System Iris Variable Aperture Collimator

  • Model / Serial
    All units of these models.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
  • Product Description
    Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Manufacturer Parent Company (2017)
  • Source
    USFDA