BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2261-2012 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2261-2012
    Event ID
    62871
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Galil Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    July 20, 2012
    Classification Date
    August 23, 2012
    Termination Date
    September 13, 2012
    Address
    4364 Round Lake Rd W, N/A, Arden Hills, MN, 55112, United States

    Description

    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.

    Reason

    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.

    Code Info

    VL0004 VL0014 VL0015 VL0016

    Distribution

    Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands

    Quantity

    4