Class 2 Device Recall VisualICE Cryoablation System

• Date Initiated by Firm: October 25, 2019
• Create Date: November 14, 2019
• Recall Status: Terminated on September 16, 2020
• Recall Number: Z-0404-2020
• Recall Event ID: 84120
• 510(K)Number: K113860 K123865 K143564
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: Visual-ICE Cryoablation System, FPRCH6000.; The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively , by the use of Galil Medical I-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
• Code Information: System Serial Number / PM Kit #: VL0031 / PM0506M, VL0036 / PM0546M, VL0067 / PM0515M, VL0069 / PM0565M, VL0075 / PM0532M, VL0079 / PM0539M, VL0082 / PM0491M, VL0085 / PM0486M, VL0086 / PM0499M, VL0088 / PM0489M, VL0090 / PM0513M, VL0092 / PM0548M, VL0093 / PM0544M, VL0094 / PM0520M, VL0100 / PM0516M, VL0102 / PM0529M, VL0105 / PM0560M, VL0112 / PM0542M, VL0115 / PM0525M, VL0136 / PM0561M, VL0148 / PM0514M, VL0153 / PM0531M, VL0171 / PM0564M, VL0175 / PM0559M, VL0181 / PM0512M, VL0186 / PM0533M, VL0191 / PM0492M, VL0220 / PM0545M, VL0230 / PM0528M, VL0238 / PM0500M, VL0249 / PM0498M, VL0271 / PM0497M, VL0275 / PM0543M, VL0280 / PM0549M, VL0283 / PM0488M, VL0285 / PM0566M, VL0287 / PM0562M, VL0291 / PM0524M, VL0300 / PM0550M, VL0301 / PM0541M, VL0303 / PM0530M, VL0304 / PM0563M, VL0308 / PM0523M, VL0309 / PM0507M, VL0310 / PM0490M, VL0311 / PM0555M, VL0312 / PM0526M, VL0321 / PM0552M, VL0362 / PM0527M.
• Recalling Firm/ Manufacturer: Galil Medical, Inc.; 4364 Round Lake Rd W; Saint Paul MN 55112-3923
• For Additional Information Contact: Quality Assurance Department; 877-639-2796
• Manufacturer Reason for Recall: Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
• FDA Determined Cause: Environmental control
• Action: An Urgent Medical Device Correction letter was emailed to customers beginning 10/25/2019. A hard copy of this letter was sent by USPS. The letter identified the affected devices, stated the issue, instructed not to use the IceSeed 1.5 or Ice Rod 1.5 PLUS needles until a preventive maintenance activity, to replace the desiccant tubes, has been done by an authorized service engineer.
• Quantity in Commerce: 49 systems
• Distribution: AK, AL, AR, AZ, CA, FL, GA, HI, KY, MA, MI, MN, NC, ND, NY, OH, PA, SC, TN, UT, VA, Puerto Rico OUS to include: Argentina, Canada, Taiwan, United Kingdom
• 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.