Recall Z-0404-2020— Galil Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Galil Medical, Inc., initiated 2019-10-25, terminated 2020-09-16. It names 3 FDA 510(k) clearances: K143564, K123865, K113860. 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.. Reason: 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..
- Recalling firm
- Galil Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-25
- Terminated
- 2020-09-16
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
3 on FDA's record- K143564 — Visual-ICE Cryoablation System, Software Revision 1.3.1
- K123865 — VISUAL-ICE CRYOABLATION SYSTEM
- K113860 — VISUAL-ICE CRYOABLATION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.