{ "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": "103932", "product_res_number": "Z-0325-2012", "event_date_initiated": "2010-03-01", "event_date_posted": "2011-12-01", "recall_status": "Terminated", "event_date_terminated": "2013-05-30", "res_event_number": "59885", "product_code": "JAQ", "k_numbers": [ "K071467" ], "product_description": "VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader.\n\nThe VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.", "code_info": "Serial numbers: 212, 215, 222, 224, 239, 246, 271, 274, 281, 293, 308, 322, 333, 343, 346, 388, 394, 401, 403, 406, 411, 431, 436, 437, 438, 441, 444, 446, 450, 456, 462, 500, 501, 505, 509, 510, 511, 512, 513, 514, 515, 516, 518, 519, 521, 522, 527, 530, 532, 535, 536, 538, 539, 540, 541, 542, 544, 545, 546, 548, 551. Part Number: AL20020000 (VariSource iX Afterloader", "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": "VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.", "root_cause_description": "Software design", "action": "Varian Medical Systems sent a \"MEDICAL DEVICE RECALL\" letter dated April 1, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to conduct a simple test to establish if their machine is affected by the problem. Device users were requested to complete an attached receipt verification form and return it to Varian BrachyTherapy via fax or e-mail. Call the Contact Service Dispatch number at 1-800-864-1672 for questions regarding this detail.", "product_quantity": "72 worldwide/50 in U.S.", "distribution_pattern": "Worldwide Distribution-USA (nationwide)", "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" } } ] }