{ "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": "103820", "product_res_number": "Z-0327-2012", "event_date_initiated": "2008-09-30", "event_date_posted": "2011-12-01", "recall_status": "Terminated", "event_date_terminated": "2011-12-07", "res_event_number": "59779", "product_code": "JAQ", "k_numbers": [ "K983436" ], "product_description": "GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany.\n\nThe interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.", "code_info": "Part number GM11007570", "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 Ext. 232", "reason_for_recall": "Plastic needle tip could possibly crack or separate.", "root_cause_description": "Nonconforming Material/Component", "action": "Varian Medical Systems sent a \"CUSTOMER TECHNICAL BULLETIN\" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.", "product_quantity": "1716 parts", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the states of Arizonia, California, Florida, Illinois, Indiana, Michigan, North Carolina, and Vermont, and the countries of Argentina, Austria, Belgium, Canada, Estonia, France, Germany, India, Norway, Pakistan, Russia, Slovenia, So. Africia, Spain, Switzerland, United Kingdom, and Ukraine.", "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" } } ] }