Device Recall AMS GreenLight PV Surgical Laser System

  • 모델명 / 제조번호(시리얼번호)
    All units of the model.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including US
  • 제품 설명
    AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; || Product is manufactured and distributed by AMS Solutions, || San Jose, CA || The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA