Galil Medical, Inc. 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 c Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AK, AZ, AR, CA, FL, GA, HI, KY, MA, MI, MN, NY, NC, ND, OH, PA, SC, TN, UT, VA, PR