# FDA recall Z-0404-2020

> **Galil Medical, Inc.** · Class II · device recall initiated 2019-10-25.

## 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 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.

## Distribution

AK, AL, AR, AZ, CA, FL, GA, HI, KY, MA, MI, MN, NC, ND, NY, OH, PA, SC, TN, UT, VA, Puerto Rico  OUS to include:  Argentina, Canada, Taiwan, United Kingdom

## Key facts

- **Recall number:** Z-0404-2020
- **Recalling firm:** Galil Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-25
- **Report date:** 2019-11-20
- **Termination date:** 2020-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0404-2020

## Citation

> AI Analytics. FDA recall Z-0404-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0404-2020. Source: US FDA. Licensed CC0.

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