{ "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": "103877", "product_res_number": "Z-0295-2012", "event_date_initiated": "2008-08-05", "event_date_posted": "2011-11-30", "recall_status": "Terminated", "event_date_terminated": "2011-12-07", "res_event_number": "59856", "product_code": "JAQ", "k_numbers": [ "K983436" ], "product_description": "GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. \n\nDesigned for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.", "code_info": "Part number GM11002560, Lots E01 to H14", "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": "GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.", "root_cause_description": "Process control", "action": "Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact information.", "product_quantity": "653 parts", "distribution_pattern": "Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missouri, Nebraska, Mississippi, New Jersey, Nevada, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin, and the countries of Austria, Azerbaijan, Brazil, British Columbia, Canada, Chile, Germany, Greece, India, India, Ireland, Israel, Mexico, Morocco, Pakistan, Poland, Republic of Macedonia, Russia, Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Ukraine, and Venezuela.", "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" } } ] }