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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62871
Product Type Devices
Status Completed
Recalling Firm Galil Medical, Inc.
City Arden Hills
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Visual-ICEĀ® 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. VL0004 VL0014 VL0015 VL0016 Class II 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. 4 Z-2261-2012