{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "177252", "product_res_number": "Z-0404-2020", "event_date_initiated": "2019-10-25", "event_date_created": "2019-11-14", "recall_status": "Terminated", "event_date_terminated": "2020-09-16", "res_event_number": "84120", "product_code": "GEH", "k_numbers": [ "K113860", "K123865", "K143564" ], "product_description": "Visual-ICE Cryoablation System, FPRCH6000.\nThe 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.", "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.", "firm_fei_number": "3004462490", "recalling_firm": "Galil Medical, Inc.", "address_1": "4364 Round Lake Rd W", "city": "Saint Paul", "state": "MN", "postal_code": "55112-3923", "additional_info_contact": "Quality Assurance Department\n877-639-2796", "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_description": "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.", "product_quantity": "49 systems", "distribution_pattern": "AK, AL, AR, AZ, CA, FL, GA, HI, KY, MA, MI, MN, NC, ND, NY, OH, PA, SC, TN, UT, VA, Puerto Rico\nOUS to include: Argentina, Canada, Taiwan, United Kingdom", "openfda": { "k_number": [ "K953294", "K172041", "K082074", "K121507", "K060279", "K103310", "K140314", "K110946", "K971392", "K832140", "K253230", "K011073", "K060859", "K011074", "K002615", "K072651", "K810409", "K940140", "K171522", "K091721", "K971216", "K982055", "K111042", "K182392", "K102360", "K161337", "K193665", "K040809", "K173037", "K980668", "K800335", "K062896", "K223369", "K955011", "K141485", "K260377", "K172049", "K052259", "K240892", "K152337", "K060928", "K072883", "K181153", "K190747", "K211099", "K961219", 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