Device Recall Synergy xray volume imaging (XVI); Elekta Synergy; Elekta Synergy S and XVI

  • Model / Serial
    Model 4.2.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Pakistan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, and United Kingdom.
  • Product Description
    Synergy XVI || The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
  • Source
    USFDA