Galil Medical, Inc.: Medical Device Recalls in 2019

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Galil Medical, Inc. in 2019. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

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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.