Device Recall CyberKnife Treatment Planning System

  • Model / Serial
    All products are affected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV, and countries including: Japan, China, Vietnam, Taiwan/China, South Korea, Hong Kong/China, Thailand and Malaysia.
  • Product Description
    CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. || Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Accuray Inc, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    All systems with multiplan tratment planning system software version 3.5
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA and countries including: Canada, Turkey, India, Italy, France, the Netherlands, the UK, India, Spain, Greece, Saudi Arabia, Switzerland, Germany and China.
  • Product Description
    CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 || Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer