Device Recall VisualICE Cryoablation System

  • 모델명 / 제조번호(시리얼번호)
    VL0004 VL0014 VL0015 VL0016
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
  • 제품 설명
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 || Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • 제조사 모회사 (2017)
  • Source
    USFDA