Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Visual-ICE Cryoablation System Recalled by Galil Medical, Inc. Due to Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Galil Medical, Inc. directly.
Affected Products
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.
Quantity: 49 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 21 states: AL, AK, AZ, AR, CA, FL, GA, HI, KY, MA, MI, MN, NY, NC, ND, OH, PA, SC, TN, UT, VA
About Galil Medical, Inc.
Galil Medical, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report