Helion and Xenion surgical lights

  • Model / Serial
    Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.
  • Product Description
    Helion and Xenion surgical lights, 501/01 series KLM lights. || The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492
  • Manufacturer Parent Company (2017)
  • Source
    USFDA