Device Recall VersaCut Morcellator

  • 모델명 / 제조번호(시리얼번호)
    Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark.
  • 제품 설명
    The Lumenis VersaCut Tissue Morcellator || Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Lumenis Limited, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • 제조사 모회사 (2017)
  • Source
    USFDA