{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104834", "product_res_number": "Z-0330-2012", "event_date_initiated": "2011-10-06", "event_date_posted": "2011-12-01", "recall_status": "Terminated", "event_date_terminated": "2012-10-22", "res_event_number": "60231", "product_code": "JAQ", "k_numbers": [ "K891131" ], "product_description": "Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH,\nBergische Strasse 16, D-42781 Haan, Germany.\n\nThe Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.", "code_info": "CODES:   H630164 ,H630703 ,H630727 ,H630756 ,H630787 ,H630810 ,H630829 ,H630850 ,H630868 ,H630888 ,H630165 ,H630705 ,H630728 ,H630757 ,H630789 ,H630811 ,H630832 ,H630851 ,H630869 ,H630889 ,H630168 ,H630706 ,H630729 ,H630758 ,H630790 ,H630812 ,H630833 ,H630852 ,H630870 ,H630891 ,H630170 ,H630711 ,H630732 ,H630760 ,H630792 ,H630813 ,H630834 ,H630854 ,H630871 ,H630892 ,H630205 ,H630712 ,H630733 ,H630764 ,H630793 ,H630814 ,H630835 ,H630855 ,H630872 ,H630895 ,H630206 ,H630713 ,H630736 ,H630769 ,H630794 ,H630815 ,H630837 ,H630857 ,H630877 ,H630896 ,H630210 ,H630714 ,H630737 ,H630771 ,H630795 ,H630817 ,H630839 ,H630858 ,H630878 ,H630897 ,H630211 ,H630716 ,H630739 ,H630774 ,H630798 ,H630818 ,H630841 ,H630859 ,H630879 ,H630898 ,H630214 ,H630718 ,H630741 ,H630776 ,H630801 ,H630820 ,H630842 ,H630860 ,H630880 ,H630901 ,H630215 ,H630719 ,H630744 ,H630777 ,H630802 ,H630822 ,H630843 ,H630863 ,H630881 ,H630902 ,H630216 ,H630720 ,H630747 ,H630778 ,H630804 ,H630825 ,H630845 ,H630864 ,H630884 ,H630903 ,H630219 ,H630721 ,H630749 ,H630781 ,H630807 ,H630826 ,H630847 ,H630866 ,H630885 ,H630904 ,H630701 ,H630722 ,H630753 ,H630784 ,H630809 ,H630828 ,H630848 ,H630867 ,H630886", "firm_fei_number": "2916710", "recalling_firm": "Varian Medical Systems, Inc. Oncology Systems", "address_1": "911 Hansen Way", "city": "Palo Alto", "state": "CA", "postal_code": "94304-1028", "additional_info_contact": "Michael A. Pignataro \n650-424-5731", "reason_for_recall": "The Product Models 1 & 2 have a design flaw problem where the clamping adapter can\nobstruct movement of the source cable in the event the bronchial catheter is dislodged\nfrom the connector.", "root_cause_description": "Device Design", "action": "Varian Medical Systems sent an \"URGENT MEDICAL DEVICE CORRECTION LETTER/FIELD SAFETY NOTICE\" letter dated October 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Contact the Varian Help Desk at 1-888-827-4265 for questions regarding this notice.", "distribution_pattern": "Worldwide Distribution--USA (nationwide).", "openfda": { "k_number": [ "K022739", "K092822", "K092405", "K232623", "K181903", "K810051", "K062135", "K242961", "K030558", "K080871", "K140803", "K123941", "K172533", "K990990", "K953946", "K062826", "K120993", "K955844", "K240495", "K925956", "K080791", "K781274", "K032372", "K201272", "K961601", "K060299", "K983341", "K902533", "K183332", "K983338", "K073133", "K032067", "K834308", "K011690", "K052947", "K152018", "K251037", "K233628", "K160516", "K040704", "K150979", "K201279", "K160045", "K852842", "K091378", "K912555", "K141490", "K243045", "K061354", "K990753", "K071229", "K092804", "K922564", "K041933", "K041715", "K052351", "K073107", "K091154", "K250289", "K031524", "K142597", "K142719", "K132097", "K853912", "K151272", "K120344", "K062830", "K172675", "K162533", "K161540", "K151022", "K915622", "K091230", "K042586", "K252717", "K881665", "K890799", "K052595", "K001544", "K844714", "K093291", "K113766", "K071381", "K262383", "K130251", "K922554", "K161576", "K983436", "K243939", "K130757", "K162499", "K200221", "K000081", "K082653", "K060349", "K092534", "K221797", "K033371", "K913908", "K042360", "K080565", "K160021", "K003270", "K063815", "K980576", "K891131", "K111973", "K061241", "K062824", "K091598", "K864210", "K030110", "K901615", "K080934", "K010032", "K171631", "K041929", "K915367", "K141624", "K161688", "K132874", "K920431", "K881323", "K101411", "K011657", "K023220", "K983115", "K040541", "K123442", "K901589", "K241853", "K022635", "K954467", "K060532", "K020176", "K051423", "K945383", "K162615", "K191580", "K222775", "K123912", "K122236", "K123815", "K112420", "K031273", "K840127", "K981886", "K241386", "K081677", "K983337", "K070659", "K252884", "K142330", "K170203", "K172611", "K133922", "K061582", "K120731", "K071467", "K120341", "K132889", "K241764", "K890294", "K914578", "K033828", "K081079", "K081179", "K964910", "K150839", "K943109", "K250299", "K832789", "K031158", "K160815", "K122840", "K980590", "K082530", "K993472", "K062241", "K051753", "K020015", "K232949", "K193240", "K063381", "K070574", "K103215", "K142986", "K923738", "K160610", "K894381", "K063382", "K180069", "K141336", "K142439", "K092323", "K021286", "K952913", "K230155", "K052228", "K980601", "K151657", "K062823", "K233626", "K993400", "K241965", "K001825", "K162018", "K082264" ], "registration_number": [ "3012536737", "2029275", "1220477", "1650907", "3011106828", "1417485", "2021969", "3034286426", "8010168", "3038188187", "3008236846", "3000270450", "3014246639", "1649518", "3016602874", "3033589330", "1222780", "1120804", "2032112", "3007200016", "1644312", "3019543601", "9611894", "3009417901", "2022435", "3004784537", "2518443", "9610348", "3010813819", "1422634", "2246552", "3015225571", "1721504", "3003660614", "2032338", "3015232217", "2022694", "2431392", "1219183", "3015309643", "1181121", "3006950086", "3032638959", "2184007", "3004111573", "1000523114" ], "fei_number": [ "3012536737", "3001236277", "1000453845", "3003295907", "1220477", "3003076831", "3011106828", "1417485", "2021969", "1937223", "3038188187", "3008236846", "3000270450", "3014246639", "3016602874", "1000115748", "3002681132", "1000514656", "3033589330", "1120804", "3007200016", "3019543601", "1000306431", "3009417901", "2022435", "3002807741", "3004784537", "2518443", "1000120743", "3010813819", "3002806617", "2246552", "1000117748", "3015225571", "3003660614", "1721504", "3015232217", "2022694", "2431392", "1219183", "3015309643", "1181121", "3006950086", "3032638959", "3004111573", "1000523114" ], "device_name": "System, Applicator, Radionuclide, Remote-Controlled", "medical_specialty_description": "Radiology", "regulation_number": "892.5700", "device_class": "2" } } ] }