Device Recall VisualICE Cryoablation System

  • Modelo / Serial
    VL0004 VL0014 VL0015 VL0016
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA