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U.S. Department of Health and Human Services

Class 2 Device Recall VisualICE Cryoablation System

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  Class 2 Device Recall VisualICE Cryoablation System see related information
Date Initiated by Firm July 20, 2012
Date Posted August 23, 2012
Recall Status1 Terminated 3 on September 13, 2012
Recall Number Z-2261-2012
Recall Event ID 62871
510(K)Number K113860  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
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.
Code Information VL0004 VL0014 VL0015 VL0016
Recalling Firm/
Manufacturer		 Galil Medical, Inc.
4364 Round Lake Rd W
Arden Hills MN 55112
For Additional Information Contact
484-530-3900 Ext. 1354
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Device Design
Action Galil Medical sent a "Voluntary Medical Device Field Correction" letter dated July 20, 2012, via UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Galil Field Service team will be contacting customers to schedule a service visit the week of July 23rd. Customers were instructed to forward and communicate this field correction notice and instructions to individuals in their organization and/or to other organizations affected by this action. For questions call Galil Medical Customer Service.
Quantity in Commerce 4
Distribution Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = GALIL MEDICAL INC.
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