Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a m ...



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.
Components:
Recall Date:    Oct 25, 2019
Mfg:
Galil Medical, Inc.
Mfg Country:
United States
Recall ID:    84120
Product ID:    177252
Enforcement Date:    Nov 20, 2019
Termination Date:    Sep 16, 2020
Last Published:    Sep 16, 2020

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Emert Number:    Z-0404-2020
Emert Status:    Terminated