{ "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": "48382", "product_res_number": "Z-0486-2007", "event_date_initiated": "2006-09-11", "event_date_posted": "2007-01-11", "recall_status": "Terminated", "event_date_terminated": "2007-05-18", "res_event_number": "36304", "product_code": "JAQ", "k_numbers": [ "K891131", "K912555" ], "product_description": "GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA", "code_info": "H630701 H630703 H630704 H630705 H630706 H630708 H630710 H630711 H630712 H630713 H630714 H630715 H630716 H630718 H630719 H630720 H630721 H630722 H630723 H630724 H630725 H630727 H630728 H630729 7H63030 H630732 H630733 H630735 H630736 H630737 H630739", "firm_fei_number": "3000206172", "recalling_firm": "Varian Medical Systems", "address_1": "700 Harris Street", "address_2": "Suite 109", "city": "Charlottesville", "state": "VA", "postal_code": "22903-4584", "additional_info_contact": "Mark Kattmann\n434-977-8495 Ext. 232", "reason_for_recall": "Medical device for patient treatment does not meet electrical safety standards.", "root_cause_description": "Other", "action": "The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.", "product_quantity": "31 total units", "distribution_pattern": "Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.", "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" } } ] }