medical Class II Updated 2019-11-20

Galil Medical, Inc. recalls Visual-ICE Cryoablation System, FPRCH6000. The cryoablation

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: AK, AL, AR, AZ, CA, FL, GA, HI, KY, MA, MI, MN, NC, ND, NY, OH, PA, SC, TN, UT, VA
Lot/Code Info: System Serial Number / PM Kit #: VL0031 / PM0506M, VL0036 / PM0546M, VL0067 / PM0515M, VL0069 / PM0565M, VL0075 / PM0532M, VL0079 / PM0539M, VL0082 / PM0491M, VL0085 / PM0486M, VL0086 / PM0499M, VL0088 / PM0489M, VL0090 / PM0513M, VL0092 / PM0548M, VL0093 / PM0544M, VL0094 / PM0520M, VL0100 / PM0516M, VL0102 / PM0529M, VL0105 / PM0560M, VL0112 / PM0542M, VL0115 / PM0525M, VL0136 / PM0561M, VL0148 / PM0514M, VL0153 / PM0531M, VL0171 / PM0564M, VL0175 / PM0559M, VL0181 / PM0512M, VL0186 / PM0533M, VL0191 / PM0492M, VL0220 / PM0545M, VL0230 / PM0528M, VL0238 / PM0500M, VL0249 / PM0498M, VL0271 / PM0497M, VL0275 / PM0543M, VL0280 / PM0549M, VL0283 / PM0488M, VL0285 / PM0566M, VL0287 / PM0562M, VL0291 / PM0524M, VL0300 / PM0550M, VL0301 / PM0541M, VL0303 / PM0530M, VL0304 / PM0563M, VL0308 / PM0523M, VL0309 / PM0507M, VL0310 / PM0490M, VL0311 / PM0555M, VL0312 / PM0526M, VL0321 / PM0552M, VL0362 / PM0527M.
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