{ "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": 11 } }, "results": [ { "cfres_id": "50198", "product_res_number": "Z-0546-2007", "event_date_initiated": "2007-01-10", "event_date_posted": "2007-02-27", "recall_status": "Terminated", "event_date_terminated": "2009-07-27", "res_event_number": "37252", "product_code": "DRG", "k_numbers": [ "K030795" ], "product_description": "LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223", "code_info": "C6310, C6324 and C6297.", "firm_fei_number": "1000403400", "recalling_firm": "GMP Companies/Lifesync Corporation", "address_1": "One E. Broward Blvd.", "address_2": "Suite 1701", "city": "Ft Lauderdale", "state": "FL", "postal_code": "33301", "reason_for_recall": "When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.", "root_cause_description": "Other", "action": "The recall was initiated on January 15, 2007. The firm''s representatives, hand carried, Device Recall Letter to Account Representative and Risk Manager. Distributors who received the Device Recall Letter, purged their stock of the affected devices and notified their customers.\n\t\nRecall Communication was hand carried to each account with 100% compliance by LifeSync Clinical/Sales Personnel. EFFECTIVENESS CHECKS of this recall will be achieved through Return Material Authorization via telephone with each affected account.", "product_quantity": "272 cases", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K091220", "K211305", "K790109", "K063484", "K212957", "K211365", "K241101", "K150289", "K092635", "K124000", "K132173", "K071564", "K133587", "K202868", "K073710", "K802357", "K190916", "K873672", "K073038", "K071058", "K123229", "K111854", "K981533", "K111922", "K002089", "K002514", "K083046", "K993550", "K813064", "K062662", "K061606", "K132148", "K050778", "K170204", "K132803", "K880036", "K170973", "K123671", "K120470", "K250259", "K242018", "K803229", "K100524", "K052608", "K080091", "K914889", "K103796", "K093134", "K964554", "K810331", "K193343", "K141167", "K050929", "K130821", "K222398", "K133252", "K083115", "K772000", "K940009", "K130971", "K191614", "K050128", "K103276", "K101242", "K091430", "K120253", "K171188", "K102106", "K112559", "K171406", "K081499", "K122095", "K131913", "K061088", "K183078", "K030795", "K100427", "K181248", "K141792", "K781836", "K934711", "K223711", "K802273", "K022274", "K062215", "K040663", "K141706", "K171029", "K850166", "K173510", "K050567", "K122763", "K973873", "K040966", "K071953", "K181196", "K062127", "K113493", "K935839", "K134004", "K223073", "K062304", "K243837", "K191620", "K191331", "K030222", "K072698", "K945578", "K101078", "K070543", "K163453", "K211822", "K221530", "K910620", "K133997", "K974149", "K122458", "K790144", "K844376", "K091021", "K101834", "K051470", "K023749", "K120325", "K801944", "K103214", "K122333", "K130290", "K891104", "K172329", "K200690", "K172011", "K182297", "K161916", "K061087", "K132447", "K141020", "K090886", "K163694", "K110334", "K130676", "K823906", "K120895", "K122285", "K220526", "K120704", "K252440", "K252984", "K832817", "K192875", "K100508", "K153719", "K130360", "K013533", "K851302", "K945037", "K821384", "K083331", "K103643", "K090610", "K791363", "K110809", "K080798", "K093895", "K091696", "K061502", "K120941", "K823249", "K101178", "K041816", "K052961", "K072008", "K000276", "K946175", "K090801", "K132930", "K191870", "K261569", "K113446", "K212883", "K993169", "K112858", "K802849", "K063612", "K192757", "K240251", "K152139", "K904748", "K171019", "K860239", "K083862", "K213233" ], "registration_number": [ "3012494290", "3018188848", "3033715634", "3005334138", "3013319763", "3009077524", "3001570235", "1000548922", "3004485927", "3017643152", "3009600098", "3014848734", "3026960443", "3009499478", "3010552191", "1223925", "3013783488", "3010698831", "3044675072", "3015328411", "9681377", "3004145393", "3016618143", "3042272797", "3009896984", "3022123357", "3017961114", "3009503584", "3004111573", "3008058132", "1054811", "3025330366", "3008101184", "8030229", "2221819", "2124215", "3004091615", "1218950", "3008729547", "3014640930", "3030154814", "1651104", "3016852448", "1721686", "1713468", "3021559257", "3004091281", "3013501110", "2080783", "3021988268", "3033118181", "3004748528", "3019737388", "3031841433", "1033601", "1930027", "3014856521", "3000126629", "3006948155", "3013791928", "3013319212", "2183613", "3015529350", "3013896610", "3015134004", "1523530", "2134265", "3009456923", "2184149", "3008460104", "9680215", "3012933969", "3003982635", "3007134734", "1063285", "2133928", "3043479346", "3009735945", "3008717264", "8020045", "3011651103", "3008114669", "9611252", "3009156722", "3017446092", "3029904429", "3017986070", "1320894", "1527715", "3044754336", "3015181391", "2029275", "3010536822", "9610816", "3007413079", "3016592682", "3027510187", "3016595211", "2134285", "3012606445", "3014886121", "3007048291", "3004727197", "3003263092", "3005941719", "3038761440", "2024168", "3012359877", "3016701404", "3013546957", "3003832357", "3012528160", "3013596024", "1319639", "3014541700", "3012302888", "3015455735", "3009564766", "3007603826", "3013500228", "3015907115", "3005438755", "9610105", "3010703925", "3003971136", "3006240053" ], "fei_number": [ "3012494290", "3018188848", "3033715634", "3005334138", "3013319763", "3009077524", "3002807720", "3001570235", "1000548922", "3001451571", "3004485927", "3017643152", "3002807739", "3009600098", "3014848734", "3026960443", "3009499478", "3013783488", "3006254866", "3010698831", "3044675072", "1000306431", "3015328411", "3004145393", "3016618143", "3042272797", "3009896984", "3017961114", "3009503584", "3004111573", "3008058132", "3009865005", "3025330366", "3008101184", "1000138054", "3002095335", "1000300598", "2221819", "2124215", "3004091615", "1218950", "3008729547", "3014640930", "3030154814", "1000403400", "3016852448", "1721686", "1713468", "3021559257", "3013501110", "6736", "2080783", "3002806783", "3021988268", "3033118181", "3004748528", "3019737388", "3031841433", "1033601", "1930027", "3014856521", "3000126629", "3013791928", "3013319212", "2183613", "3015529350", "3013896610", "3015134004", "3001084824", "1523530", "3009456923", "3008460104", "3010830833", "3012933969", "3003982635", "3007134734", "3043479346", "1000139754", "3009735945", "3008717264", "3011651103", "3008114669", "3009156722", "3017446092", "3029904429", "1000114185", "3017986070", "3015191855", "1527715", "3002287318", "3002807167", "3044754336", "3015181391", "3010536822", "3007413079", "3016592682", "3027510187", "1000305720", "3016595211", "3012606445", "3014886121", "3007048291", "3004727197", "3003263092", "3038761440", "2024168", "3012359877", "3016701404", "3013546957", "3002807111", "3003832357", "3012528160", "3013596024", "3014541700", "3012302888", "3000717902", "3015455735", "3009564766", "3007603826", "3002737156", "3013500228", "3015907115", "3005438755", "3010703925", "3003971136", "3006240053" ], "device_name": "Transmitters And Receivers, Physiological Signal, Radiofrequency", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2910", "device_class": "2" } } ] }