Device Recall Helion S Exam Light or H300

  • Model / Serial
    Unknown
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
  • Product Description
    Helion S Exam Light or H300 || The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492-7906
  • Manufacturer Parent Company (2017)
  • Source
    USFDA