Device Recall TruLight ALC, Trulight 5520 or 5320 lighting system.

  • 모델명 / 제조번호(시리얼번호)
    Material number 1583966
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MO, NC, NM, NJ, NY, OH, PA, TX, VA, VT, WA, and WI; and countries of: Australia; Austria, Belguim, China, Cyprus, Denmark, Estonia, Finland, France, Germany, Great Britain, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea, Latvia, Luxembourg, Mexico, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Seychelles, Singapore, South Africa (Zuid Afirka), Spain, Sweden, Switzerland (Confederation of Helvetia), Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.
  • 제품 설명
    Surgical lighting systems iLED and TruLight in use with the ALC+ function. || The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492
  • 제조사 모회사 (2017)
  • Source
    USFDA