Z-0404-2020Class II

Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for...

Name: Z-0404-2020 Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for...
Creator: Galil Medical, Inc.
Published: 2019-10-25
License: https://open.fda.gov/license/

Galil Medical Ltd. / initiated 2019-10-25 / Terminated / root cause: manufacturing process

FDA source

Galil Medical, Inc. began a recall of Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally... on 2019-10-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0404-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-25
Posted: 2019-11-14
Terminated: 2020-09-16
Recalling firm: Galil Medical Ltd.
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.
Product code: GEH Unit, Cryosurgical, Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: An Urgent Medical Device Correction letter was emailed to customers beginning 10/25/2019. A hard copy of this letter was sent by USPS. The letter identified the affected devices, stated the issue, instructed not to use the IceSeed 1.5 or Ice Rod 1.5 PLUS needles until a preventive maintenance activity, to replace the desiccant tubes, has been done by an authorized service engineer.
Quantity in commerce: 49 systems
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0404-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0404-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14

Product code GEH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)