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.
FDA Recall Z-0404-2020 · Posted None
Recalling FirmGalil Medical, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2019-10-25
Date Terminated2020-09-16
Product Quantity49 systems
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.
Firm 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.
Root Cause
Environmental control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.