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Galil Medical, Inc. recalls Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is
Recalled August 29, 2012 · FDA recall Z-2261-2012 · Galil Medical
Hazard
Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable. · FDA Class II
Units
4
Sold at
Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
Description
Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
Product
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(s)
Galil Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →