{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "103990", "product_res_number": "Z-0282-2012", "event_date_initiated": "2010-05-20", "event_date_posted": "2011-11-23", "recall_status": "Terminated", "event_date_terminated": "2011-12-05", "res_event_number": "59913", "product_code": "JAQ", "k_numbers": [ "K033371" ], "product_description": "Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)", "code_info": "Lot number Y01 to E19", "firm_fei_number": "3000206172", "recalling_firm": "Varian Medical Systems, Inc.", "address_1": "700 Harris St Ste 109 700 Harris St", "address_2": "Ste 109", "city": "Charlottesville", "state": "VA", "postal_code": "22903-4584", "additional_info_contact": "Mark Kattmann\n434-977-8495", "reason_for_recall": "The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.", "root_cause_description": "Labeling Change Control", "action": "Varian Medical Systems sent a Medical Device Recall (PNL-GM-42697-2) in May 2010 for the blocking washer on the flexible probe, Varian part number GM11002420, a component of the Segmented Cylinder Applicator Set. The letter was to inform users that a flexible probe with an unstable or shifted blocking washer must not be used due to the potential for treatment length error. The blocking washer may move from rough handling or sterilization. Users were told to discard any instances of the obsolete Instructions for Use (IFU) in use and replace it with the IFU (PGM11004150 4 March 24, 2010.pdf). A Receipt Verification Card was included requesting consignees to fill out, fax or e-mail immediately to Varian BrachyTherapy.", "product_quantity": "81 parts", "distribution_pattern": "Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India", "openfda": { "k_number": [ "K003270", "K191580", "K011657", "K864210", "K914578", "K922554", "K001825", "K040704", "K060299", "K983436", "K925956", "K162533", "K132874", "K221797", "K252884", "K032067", "K020176", "K120341", "K810051", "K091598", "K990753", "K101411", "K160045", "K031158", "K080791", "K120993", "K853912", "K890799", "K890294", "K141490", "K081677", "K052595", "K021286", "K141624", "K023220", "K961601", "K073133", "K200221", "K233628", "K232623", "K092804", "K062135", "K092534", "K123815", "K954467", "K262383", "K091230", "K081179", "K142439", "K902533", "K062824", "K063381", "K915367", "K162615", "K151022", "K082264", "K011690", "K133922", "K881323", "K983341", "K943109", "K042586", "K062823", "K852842", "K061354", "K142986", "K061582", "K031524", "K142597", "K082653", "K081079", "K130251", "K061241", "K241386", "K020015", "K241764", "K181903", "K092822", "K122840", "K981886", "K250289", "K103215", "K240495", "K983115", "K062830", "K031273", "K161576", "K040541", "K161540", "K242961", "K080565", "K781274", "K150979", "K901589", "K170203", "K152018", "K915622", "K160516", "K051423", "K172611", "K251037", "K080934", "K122236", "K032372", "K041715", "K080871", "K070659", "K111973", "K993400", "K881665", "K913908", "K000081", "K894381", "K201279", "K030110", "K132097", "K052351", "K201272", "K980590", "K964910", "K901615", "K922564", "K840127", "K140803", "K052228", "K151272", "K142330", "K172675", "K844714", "K022635", "K162499", "K834308", "K071381", "K232949", "K123442", "K241965", "K030558", "K222775", "K241853", "K990990", "K060349", "K120731", "K891131", "K923738", "K093291", "K980576", "K051753", "K063815", "K955844", "K091378", "K983338", "K183332", "K071229", "K092323", "K162018", "K172533", "K033828", "K193240", "K912555", "K042360", "K120344", "K233626", "K033371", "K832789", "K151657", "K123941", "K160021", "K230155", "K252717", "K123912", "K150839", "K092405", "K171631", "K063382", "K112420", "K073107", "K022739", "K082530", "K001544", "K041929", "K071467", "K250299", "K041933", "K060532", "K243045", "K980601", "K132889", "K010032", "K160815", "K052947", "K952913", "K130757", "K141336", "K945383", "K091154", "K953946", "K161688", "K983337", "K160610", "K142719", "K062826", "K070574", "K920431", "K062241", "K180069", "K243939", "K113766", "K993472" ], "registration_number": [ "3033589330", "3015225571", "1644312", "3011106828", "1422634", "2032338", "9610348", "3008236846", "2032112", "3014246639", "3010813819", "1649518", "3004111573", "3004784537", "9611894", "2518443", "3006950086", "3000270450", "8010168", "3038188187", "1222780", "3003660614", "1120804", "1000523114", "2431392", "1181121", "2022435", "2021969", "3034286426", "2184007", "3012536737", "1220477", "1417485", "3016602874", "3015309643", "3032638959", "2246552", "1650907", "2029275", "3007200016", "3019543601", "3015232217", "2022694", "1219183", "1721504", "3009417901" ], "fei_number": [ "3033589330", "3015225571", "1937223", "3011106828", "3008236846", "3002681132", "3001236277", "3003076831", "3014246639", "3010813819", "1000514656", "3004111573", "3004784537", "1000117748", "3006950086", "2518443", "3002806617", "3000270450", "1000115748", "3038188187", "3003295907", "3003660614", "1120804", "1000523114", "2431392", "1181121", "2022435", "2021969", "1000120743", "3012536737", "1220477", "1417485", "3016602874", "3015309643", "3032638959", "1000306431", "2246552", "3007200016", "1000453845", "3019543601", "3015232217", "2022694", "1219183", "1721504", "3002807741", "3009417901" ], "device_name": "System, Applicator, Radionuclide, Remote-Controlled", "medical_specialty_description": "Radiology", "regulation_number": "892.5700", "device_class": "2" } } ] }