Visual-ICE Cryoablation System — Class II medical device recall Z-0404-2020
Terminated recall by Galil Medical, Inc., reported 2019-11-20, distributed in AK, AL, AR, AZ, CA, FL, GA, HI…. Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needl
| Recall number | Z-0404-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galil Medical, Inc., Saint Paul, MN, United States |
| Recall initiated | 2019-10-25 |
| Classified | 2019-11-14 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2020-09-16 |
| Distributed | AK, AL, AR, AZ, CA, FL, GA, HI, KY, MA, MI, MN, NC, ND, NY, OH, PA, PR, SC, TN, UT, VA |
| Countries outside the US | AR, CA, GB, TW |
| Quantity | 49 systems |
| Serial numbers | PM0486M, PM0488M, PM0489M, PM0490M, PM0491M, PM0492M, PM0497M, PM0498M, PM0499M, PM0500M, PM0506M, PM0507M, PM0512M, PM0513M, PM0514M, PM0515M, PM0516M, PM0520M, PM0523M, PM0524M, PM0525M, PM0526M, PM0527M, PM0528M, PM0529M and 73 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0404-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.