{ "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": "31559", "product_res_number": "Z-0582-04", "event_date_initiated": "2004-02-06", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2004-09-21", "res_event_number": "28300", "product_code": "JAQ", "product_description": "EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.", "code_info": "Serial numbers (Domestic units): 724 215 765 210 212 217 218 214 767 213 743 706708 784 727 795 710 899 702 898 820 219 750 757 894 799 852 821 216 788 202 873 786 896 797 826 709 889 848", "firm_fei_number": "3000206172", "recalling_firm": "Varian Medical Systems", "address_1": "700 Harris St", "address_2": "Suite 109", "city": "Charlottesville", "state": "VA", "postal_code": "22903-4584", "additional_info_contact": "Rachel Plesko\n434-977-8495", "reason_for_recall": "Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.", "root_cause_description": "Other", "action": "The recalling firm notified end users by letters flagged 'Urgent Medical Device Correction' on 2/2/04. The notification reminds users to verify the decay factor before patient treatment. The letter also advises that instrument software be be updated commencing March 2004.", "product_quantity": "203", "distribution_pattern": "Product was distributed to end users in the United States and internationally.", "openfda": { "k_number": [ "K141336", "K142986", "K160021", "K142330", "K020176", "K141490", "K251037", "K160815", "K980601", "K181903", "K922554", "K033828", "K983338", "K252717", "K142719", "K221797", "K232623", "K133922", "K060349", "K201279", "K091378", "K890799", "K040541", "K081079", "K170203", "K092534", "K130251", "K063381", "K041929", "K160045", "K233628", "K913908", "K052947", "K201272", "K071467", "K241853", "K191580", "K894381", "K232949", "K250299", "K915622", "K241965", "K111973", "K120344", "K092405", "K945383", "K092323", "K142439", "K151657", "K844714", "K061354", "K172611", "K103215", "K160610", "K042586", "K022739", "K890294", "K032067", "K990990", "K252884", "K122236", "K063815", "K142597", "K091598", "K983337", "K062826", "K120731", "K241386", "K123815", "K082653", "K052351", "K881323", "K060299", "K171631", "K010032", "K132889", "K193240", "K183332", "K983436", "K954467", "K980576", "K881665", "K081677", "K120993", "K172675", "K071381", "K080565", "K161688", "K062135", "K130757", "K031273", "K070574", "K923738", "K073133", "K003270", "K150839", "K040704", "K021286", "K091154", "K983341", "K902533", "K961601", "K980590", "K052595", "K061582", "K840127", "K080791", "K031524", "K943109", "K023220", "K011690", "K993400", "K032372", "K051423", "K233626", "K151272", "K180069", "K200221", "K914578", "K082530", "K162533", "K031158", "K152018", "K060532", "K140803", "K041933", "K092804", "K101411", "K853912", "K071229", "K891131", "K091230", "K123941", "K864210", "K042360", "K230155", "K901589", "K030558", "K022635", "K062824", "K915367", "K901615", "K241764", "K051753", "K161576", "K964910", "K033371", "K172533", "K063382", "K981886", "K052228", "K113766", "K132097", "K162499", "K810051", "K030110", "K112420", "K093291", "K922564", "K781274", "K240495", "K062823", "K990753", "K161540", "K162615", "K001544", "K150979", "K993472", "K122840", "K955844", "K081179", "K222775", "K000081", "K925956", "K123442", "K141624", "K062830", "K082264", "K834308", "K852842", "K080871", "K952913", "K080934", "K160516", "K070659", "K120341", "K243045", "K243939", "K250289", "K062241", "K832789", "K092822", "K151022", "K242961", "K011657", "K020015", "K983115", "K912555", "K132874", "K920431", "K953946", "K001825", "K041715", "K073107", "K162018", "K061241", "K262383", "K123912" ], "registration_number": [ "9610348", "3014246639", "2032338", "1644312", "2029275", "3033589330", "3010813819", "1120804", "1000523114", "2032112", "3012536737", "1422634", "2021969", "3038188187", "3004111573", "2518443", "2022694", "3015309643", "2246552", "1417485", "1721504", "2184007", "8010168", "1181121", "3015225571", "3011106828", "2022435", "3019543601", "3009417901", "3006950086", "9611894", "1649518", "3032638959", "2431392", "3003660614", "1220477", "1222780", "3004784537", "3034286426", "3016602874", "1219183", "3015232217", "1650907", "3007200016", "3000270450", "3008236846" ], "fei_number": [ "1000117748", "3003076831", "3014246639", "3001236277", "3033589330", "3010813819", "1120804", "1000523114", "3012536737", "1000306431", "2021969", "3038188187", "3002807741", "3004111573", "2518443", "2022694", "3015309643", "2246552", "1417485", "1721504", "1937223", "1181121", "3015225571", "1000514656", "3011106828", "2022435", "3019543601", "3009417901", "3006950086", "1000120743", "3002806617", "3003295907", "3032638959", "2431392", "3003660614", "1220477", "3004784537", "3016602874", "3002681132", "1219183", "3015232217", "1000453845", "3007200016", "1000115748", "3000270450", "3008236846" ], "device_name": "System, Applicator, Radionuclide, Remote-Controlled", "medical_specialty_description": "Radiology", "regulation_number": "892.5700", "device_class": "2" } } ] }