{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "219535", "product_res_number": "Z-2710-2026", "event_date_initiated": "2026-04-03", "event_date_posted": "2026-07-09", "recall_status": "Open, Classified", "res_event_number": "98704", "product_code": "JAQ", "k_numbers": [ "K132889" ], "product_description": "Brand Name: Fletcher CT/MR Shielded Applicator Set\nProduct Name: Intracavitary Remote Afterloading Applicator\nProduct Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.", "code_info": "Lot Code: 08717213024205", "firm_fei_number": "1037831", "recalling_firm": "Elekta, Inc.", "address_1": "400 Perimeter Center Ter NE Ste 50 400 Perimeter Center Ter NE", "address_2": "Ste 50", "city": "Atlanta", "state": "GA", "postal_code": "30346-1227", "additional_info_contact": "Elekta Care Support\n001-855-6935358", "reason_for_recall": "Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.", "root_cause_description": "Process control", "action": "On 04/03/2026, an \"IMPORTANT FIELD SAFETY NOTIFICATION/URGENT: MEDICAL DEVICE CORRECTION\" Letter was sent via email informing customers of a safety concern regarding detachment of the tip of an Intrauterine tube (IU tube) with a 4 mm diameter.\n\nCustomers are instructed to:\nTo prevent any potential health risks related to a detached tip, we emphasize the importance of adhering to the Instructions for Use:\n\" Do not use an IU tube beyond its 3-year life expectancy or 300 reprocessing cycles, whichever comes first.\n\" During the treatment preparation phase, before insertion of the applicator: Visually inspect parts for indication of damage, weakening, bending, cracks, corrosion, or general deterioration.\n\" Inspect joints and connections on play, strength or other forms of degradation.\nIn addition, we recommend the following:\n\" Inspect the end of the IU tube to ensure that there is no gap between the tip and the fiber tube and that the tip is not detached.\n\" During inspection, insertion and removal: avoid the use of excessive force that could damage the IU tube.\n\" After removal: Ensure that all applicator parts have been removed from the patient and that the tip is not detached.\nIn case you find a damaged or detached IU tube tip, remove it from clinical use and contact Elekta for a replacement.\n\nFor Questions-\nRegion America\nApplication.Support.NA@elekta.com\nTel: +1 855 6935358\nhttps://www.elekta.com\nRegion Asia Pacific\nHK.TW.Support@elekta.com\nTel: + 852 2891 2208\nhttps://www.elekta.com\nJapan\nJapan-fco@elekta.com\nTel: + 81 3 6722 3800\nFax: +81 3 6436 4231\nhttps://www.elekta.com\nRegion China\nFCO.CN@elekta.com\nTel : + 86 800 810 2550\nhttps://www.elekta.com\nRegion Europe\nSupport.europe@elekta.com\nTel : + 46 8 587 254 00\nhttps://www.elekta.com\nRegion Turkey, India & Middle East\nsupport.rma@elekta.com\nTurkey\nTel: +90 216 444 6374\nIndia\nTel: +1-800-103-7454\nMiddle East\nTel: +00 800 4000 5000\nhttps://www.elekta.com", "product_quantity": "1", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.", "openfda": { "k_number": [ "K890799", "K150979", "K241764", "K891131", "K091378", "K172533", "K020015", "K171631", "K250289", "K103215", "K071381", "K081179", "K010032", "K132889", "K151657", "K023220", "K160815", "K183332", "K092804", "K022739", "K162018", "K983115", "K151022", "K021286", "K915367", "K092534", "K981886", "K954467", "K120993", "K832789", "K062241", "K080871", "K161688", "K233628", "K925956", "K031158", "K122236", "K120344", "K902533", "K071229", "K141336", "K061241", "K101411", "K120341", "K041929", "K003270", "K243939", "K955844", "K033371", "K091598", "K890294", "K881323", "K093291", "K191580", "K052947", "K150839", "K162533", "K062830", "K894381", "K040704", "K983338", "K222775", "K132097", "K082264", "K172611", "K062823", "K983341", "K082530", "K241965", "K990990", "K062824", "K993472", "K070574", "K953946", "K923738", "K152018", "K032372", "K160516", "K142439", "K983436", "K091154", "K073133", "K001825", "K081079", "K080791", "K201279", "K232949", "K983337", "K052228", "K132874", "K062135", "K142597", "K112420", "K141624", "K051753", "K063382", "K032067", "K853912", "K920431", "K062826", "K242961", "K092822", "K052351", "K240495", "K113766", "K120731", "K092405", "K162499", "K001544", "K063815", "K130757", "K141490", "K250299", "K071467", "K193240", "K914578", "K030110", "K031273", "K040541", "K913908", "K041715", "K070659", "K142330", "K130251", "K161540", "K031524", "K080934", "K161576", "K092323", "K230155", "K140803", "K051423", "K252717", "K912555", "K262383", "K151272", "K073107", "K961601", "K091230", "K080565", "K952913", "K241853", "K041933", "K030558", "K011657", "K123442", "K840127", "K232623", "K063381", "K061354", "K111973", "K020176", "K011690", "K901615", "K160610", "K172675", "K980576", "K000081", "K122840", "K864210", "K082653", "K123815", "K180069", "K123912", "K200221", "K033828", "K060299", "K061582", "K123941", "K162615", "K852842", "K844714", "K221797", "K834308", "K243045", "K964910", "K042360", "K201272", "K042586", "K901589", "K252884", "K943109", "K781274", "K881665", "K251037", "K922564", "K142719", "K810051", "K980590", "K060532", "K160021", "K022635", "K980601", "K081677", "K993400", "K052595", "K181903", "K160045", "K922554", "K060349", "K241386", "K233626", "K990753", "K915622", "K142986", "K945383", "K170203", "K133922" ], "registration_number": [ "3015225571", "3007200016", "1000523114", "2032338", "2022694", "3006950086", "2246552", "3012536737", "2184007", "8010168", "3011106828", "3033589330", "3032638959", "1650907", "1644312", "3019543601", "2431392", "3004111573", "3003660614", "3015232217", "3004784537", "1649518", "2021969", "3010813819", "2029275", "9610348", "3038188187", "1120804", "1222780", "9611894", "3009417901", "1422634", "1417485", "1219183", "2032112", "1220477", "3014246639", "3008236846", "2022435", "3015309643", "3000270450", "3034286426", "2518443", "3016602874", "1181121", "1721504" ], "fei_number": [ "1000115748", "1000453845", "3015225571", "1000306431", "3007200016", "1000523114", "2022694", "3002806617", "3006950086", "3002807741", "2246552", "3012536737", "1000120743", "1937223", "3011106828", "3033589330", "3032638959", "3019543601", "2431392", "1000117748", "1000514656", "3004111573", "3003660614", "3015232217", "3004784537", "2021969", "3010813819", "3002681132", "3038188187", "1120804", "3009417901", "1417485", "1219183", "3015309643", "1220477", "3014246639", "3008236846", "2022435", "3001236277", "3000270450", "3003076831", "3003295907", "2518443", "3016602874", "1181121", "1721504" ], "device_name": "System, Applicator, Radionuclide, Remote-Controlled", "medical_specialty_description": "Radiology", "regulation_number": "892.5700", "device_class": "2" } } ] }