Device Recall Olympus SurgMaster UES40 electrosurgical unit ("UES40")

  • 모델명 / 제조번호(시리얼번호)
    Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WY.
  • 제품 설명
    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") || Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • 제조사 모회사 (2017)
  • Source
    USFDA