{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "86625", "product_res_number": "Z-0774-2010", "event_date_initiated": "2009-11-13", "event_date_posted": "2010-03-04", "recall_status": "Terminated", "event_date_terminated": "2014-10-24", "res_event_number": "53827", "product_code": "MKJ", "k_numbers": [ "K031987", "K040438", "K052161" ], "product_description": "Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).\n\nIntended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.", "code_info": "SERIAL NUMBERS: 4107816, 4025272, 4025260, 4025300, 4025299, 4025296, 4025295, 4025293, 4025292, 4025291, 4025290, 4025284, 4025277, 4025283, 4025280, 4025279, 4025301, 4025266, 4025276, 4025275, 4025274, 4025273, 4025271, 4025270, 4025267, 4025259, 4025265, 4025264, 4025263, 4025262, 4025261, 4025285, 4025268, 4018981, 4018974, 4018988, 4018976, 4018977, 4018978, 4018990, 4018980, 4018989, 4018982, 4018983, 4018984, 4018985, 4018986, 4018987, 4018979, 4018994, 4025303, 4018991, 4025305, 4018993, 4018973, 4025306, 4025308, 4018997, 4018996, 4018975, 4018995, 4039296, 4039283, 4039328, 4039331, 4039284, 4039295, 92533-0001169, 92533-0000152, 92533-0000148, 92533-0000151, 92533-0000005, 92533-0000138, 92533-0000140, 92533-0000141, 92533-0000142, 92533-0000162, 92533-0000136, 92533-0000143, 92533-0000134, 92533-0000144, 92533-0001168, 92533-0000146, 92533-0000147, 92533-0000137, 92533-0000135, 92533-0000149, 92533-0000150, 92533-0000009, 92533-0000004, 92533-0001105, 92533-0001101, 92533-0001130, 92533-0001106, 92533-0001131, 92533-0001132, 92533-0001133, 92533-0001126, 92533-0001135, 92533-0001125, 92533-0001104, 92533-0001103, 92533-0001136, 92533-0001137, 92533-0001102, 92533-0001138, 92533-0000133, 92533-0001134, 92533-0001110, 92533-0001115, 92533-0001114, 92533-0001113, 92533-0001112, 92533-0001111, 92533-0001116, 92533-0001129, 92533-0001118, 92533-0000131, 92533-0001119, 92533-0001109, 92533-0001108, 92533-0001107, 92533-0001121, 92533-0001122, 92533-0001123, 92533-0001117, 92533-0000160, 92533-0001139, 92533-0000161, 92533-0001120, 92533-0001157, 92533-0001159, 92533-0001161, 92533-0001154, 92533-0001164, 92533-0001153, 92533-0001166, 92533-0001167, 92533-0000159, 92533-0000158, 92533-0000157, 92533-0000156, 92533-0000155, 92533-0001163, 92533-0001147, 92533-0001140, 92533-0001141, 92533-0001142, 92533-0000165, 92533-0001143, 92533-0001144, 92533-0001156, 92533-0001146, 92533-0000154, 92533-0001148, 92533-0001149, 92533-0001150, 92533-0001151, 92533-0000132, 92533-0001152, 92533-0000163, 92533-0001145, 92533-0000052, 92533-0000046, 92533-0000107, 92533-0000047, 92533-0000106, 92533-0000048, 92533-0000049, 92533-0000059, 92533-0000051, 92533-0000041, 92533-0000053, 92533-0000054, 92533-0000055, 92533-0000056, 92533-0000057, 92533-0000032, 92533-0000050, 92533-0000113, 92533-0000033, 92533-0000034, 92533-0000117, 92533-0000035, 92533-0000036, 92533-0000037, 92533-0000025, 92533-0000115, 92533-0000043, 92533-0000112, 92533-0000038, 92533-0000039, 92533-0000111, 92533-0000040, 92533-0000109, 92533-0000060, 92533-0000116, 92533-0000091, 92533-0000080, 92533-0000083, 92533-0000085, 92533-0000087, 92533-0000088, 92533-0000102, 92533-0000058, 92533-0000090, 92533-0000077, 92533-0000094, 92533-0000095, 92533-0000096, 92533-0000098, 92533-0000099, 92533-0000100, 92533-0000101, 92533-0000071, 92533-0000061, 92533-0000063, 92533-0000064, 92533-0000065, 92533-0000067, 92533-0000068, 92533-0000103, 92533-0000070, 92533-0000104, 92533-0000072, 92533-0000073, 92533-0000074, 92533-0000075, 92533-0000105, 92533-0000076, 92533-0000042, 92533-0000069, 92533-0001329, 92533-0001335, 92533-0000022, 92533-0001323, 92533-0001324, 92533-0000124, 92533-0001325, 92533-0001326, 92533-0000020, 92533-0001328, 92533-0000018, 92533-0001330, 92533-0001331, 92533-0001332, 92533-0001333, 92533-0001334, 92533-0000026, 92533-0000123, 92533-0000027, 92533-0001327, 92533-0001315, 92533-0001311, 92533-0000129, 92533-0001312, 92533-0000012, 92533-0000013, 92533-0000014, 92533-0001313, 92533-0001321, 92533-0001314, 92533-0001322, 92533-0001316, 92533-0001317, 92533-0001319, 92533-0000127, 92533-0000016, 92533-0000126, 92533-0000125, 92533-0001320, 92533-0000128, 92533-0001337, 92533-0000120, 92533-0000030, 92533-0001340, 92533-0000029, 92533-0000031, 92533-0000021, 92533-0001338, 92533-0000118, 92533-0001336, 92533-0000122, 92533-0000121, 4039293, 4018992, 4111618, 4111629, 4111617, 4111620, 4111621, 4111619, 4111628, 4111624, 4111625, 4111615, 4111612, 4111626, 4111622, 4111608, 4111605, 4111613, 4111607, 4111609, 4111610, 4111611, 4111627, 4111606, 4039310, 4039308, 4039307, 4039305, 4039304, 4039303, 4039302, 4039300, 4039299, 4039286, 4039292, 4039287, 4039288, 4039285, 4039294, 4039289, 4039290, 4039291, 4039298, 4039329, 4039312, 4039311, 4039313, 4039314, 4039332, 4039317, 4039318, 4039326, 4039319, 4039320, 4139893, 4139891, 4139894, 4139895, 4139896, 4139897, 4139898, 4139899, 4139890, 4139879, 4139900, 4139889, 4139888, 4139887, 4139886, 4139885, 4139884, 4139883, 4139882, 4139880, 4139901, 4139878, 4139881, 4139913, 4139926, 4139920, 4139925, 4139877, 4139923, 4139921, 4139919, 4139918, 4139917, 4139916, 4139924, 4139914, 4139902, 4139912, 4139911, 4139910, 4139909, 4139908, 4139907, 4139906, 4139905, 4139904, 4139903, 4139915, 4139922, 4149470, 4149489, 4149484, 4149466, 4149467, 4149469, 4149471, 4149472, 4149492, 4149493, 4149490, 4149494, 4149488, 4149487, 4149486, 4149485, 4149468, 4149482, 4149483, 4149491, 4149503, 4149512, 4149511, 4149510, 4149509, 4149508, 4149507, 4149506, 4149465, 4149504, 4149481, 4149502, 4149501, 4149500, 4149499, 4149498, 4149497, 4149495, 4149505, 4180014, 4180021, 4180016, 4180020, 4180013, 4180019, 4180018, 4180017, 4180015, 4180012, 4180011, 4180010, 4180009, 4180007, 4180006, 4180005, 4180022, 4180038, 4180001, 4180004, 4180002, 4180003, 4180008, 4180033, 4180044, 4180043, 4179962, 4180000, 4180042, 4180041, 4180040, 4180039, 4180037, 4180036, 4180034, 4180023, 4180032, 4180031, 4180030, 4180029, 4180028, 4180027, 4180026, 4180025, 4180024, 4180035, 4179958, 4179974, 4179973, 4179972, 4179971, 4179969, 4179967, 4179966, 4179963, 4179961, 4179965, 4179959, 4179977, 4179957, 4179956, 4179955, 4179954, 4179953, 4179952, 4179951, 4180045, 4179970, 4179960, 4179987, 4179998, 4179997, 4179996, 4179995, 4179994, 4179993, 4179992, 4179991, 4179990, 4179975, 4179988, 4179976, 4179986, 4179985, 4179984, 4179983, 4179982, 4179981, 4179980, 4179979, 4179978, 4179999, 4179989, 4180071, 4180046, 4179968, 4180075, 4180074, 4180072, 4180070, 4180069, 4180068, 4180067, 4180066, 4180065, 4180064, 4180063, 4180062, 4180050, 4180047, 4180048, 4180073, 4180061, 4180049, 4180051, 4180052, 4180057, 4180054, 4180055, 4180056, 4180060, 4180059, 4180053, 4180058, 4122604, 4122612, 4122611, 4122613, 4122609, 4122607, 4122606, 4122603, 4122602, 4122601, 4122600, 4122599, 4122597, 4122636, 4122614, 4122598, 4122630, 4122645, 4122643, 4122642, 4122641, 4122640, 4122639, 4122638, 4122637, 4122623, 4122635, 4122633, 4122634, 4122631, 4122615, 4122629, 4122628, 4122627, 4122626, 4122624, 4122622, 4122621, 4122620, 4122619, 4122618, 4122617, 4122616, 4122632, 4122625, 4122646, 4104173, 4104157, 4104158, 4104159, 4104160, 4104161, 4104162, 4104167, 4104168, 4104156, 4104172, 4104164, 4104176, 4104179, 4104180, 4104182, 4104184, 4104185, 4104186, 4104187, 4104188, 4104170, 4104145, 4104140, 4104142, 4104143, 4104144, 4104155, 4104146, 4104147, 4104148, 4104152, 4104150, 4104149, 4104154, 4119123, 4119126, 4119134, 4119122, 4119129, 4119125, 4119130, 4119131, 4119132, 4119139, 4119133, 4119128, 4119143, 4119140, 4119141, 4119127, 4119142, 4119121, 4119144, 4119138, 4119120, 4119137, 4111616, 4111623, 4025286, 4025289, 4025288, 4025302, 4122644, 4122610, 4122605, 92533-0000139, 92533-0000011, 92533-0000108, 92533-0001165, 92533-000084, 92533-000062, 92533-0000092, 92533-0000007, 92533-0000002, 92533-0000084, 92533-0000015, 92533-0000078, 92533-0000062, 92533-0001160, 92533-0001158, 92533-0000008, 92533-0000081, 92533-0000145, 92533-0000001, 92533-0000017, 92533-0000044, 92533-0000028, 92533-0001170, 92533-0000023, 92533-0000024, 92533-0001339, 4104139, 4104169, 4104151, 4104174, 4104141, 4104165, 4111614, 4025282, 4025269, 4039330, 4039327, 4039325, 4039324, 4039321, 4039315, 4039306, 4039297, 4149464, 4149480, 4149479, 4149463, 4149473, 4149474, 4149475, 4149476, 4149477 and 4149478.", "firm_fei_number": "2112020", "recalling_firm": "Cardiac Science Corporation", "address_1": "3303 Monte Villa Pkwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8969", "additional_info_contact": "Michael Matysik\n425-402-2206", "reason_for_recall": "Potential for devices not to deliver therapy", "root_cause_description": "Process control", "action": "Cardiac Science issued an \"Urgent - Voluntary Medical Device Correction AED Resistor Issue\" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures.\n\nFor further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.", "product_quantity": "713", "distribution_pattern": "Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.", "openfda": { "k_number": [ "K982710", "K042404", "K051632", "K883584", "K962359", "K040438", "K981802", "K123881", "K012766", "K032439", "K955882", "K033896", "K052161", "K033642", "K120406", "K860676", "K993533", "K122839", "K955923", "K954957", "K133441", "K990762", "K063510", "K052465", "K040479", "K892005", "K992977", "K982992", "K041459", "K131494", "K013425", "K110526", "K142803", "K984582", "K110154", "K030898", "K072233", "K040256", "K882067", "K023854", "K981737", "K100565", "K061707", "K972418", "K990106", "K062233", "K133484", "K081828", "K013896", "K983393", "K150198", "K892065", "K932931", "K020288", "K130153", "K052057", "K014157", "K110361", "K112761", "K022210", "K060559", "K014209", "K870622", "K935922", "K103567", "K965117", "K934692", "K041892", "K003819", "K942344", "K955854", "K040637", "K080421", "K133239", "K143714", "K992543", "K131525", "K003565", "K012428", "K051076", "K133659", "K041883", "K111594", "K051475", "K052316", "K092598", "K133269", "K003228", "K020743", "K971149", "K993072", "K002445", "K991007", "K130454", "K020715", "K082090", "K110978", "K953204", "K142915", "K926172", "K010918", "K142709", "K042088", "K955628", "K970719", "K121853", "K896919", "K033771", "K080903", "K970741", "K941262", "K031187", "K050004", "K012030", "K002280", "K112432", "K120536", "K040775", "K973486", "K972241", "K091943", "K113787", "K041067", "K020203", "K954504", "K984286", "K141231", "K952101", "K991871", "K980857", "K110825", "K120350", "K092391", "K102972", "K081371", "K000638", "K011901", "K063119", "K954609", "K072430", "K042417", "K993745", "K925936", "K081259", "K970391", "K103186", "K072812", "K062177", "K073716", "K991910", "K080232", "K063375", "K022929", "K942850", "K082937", "K022732", "K110742", "K003548", "K122600", "K010207", "K032421", "K091548", "K021168", "K011541", "K020984", "K982264", "K073089", "K943698", "K131550", "K940445", "K130684", "K122758", "K991556", "K141774", "K993036", "K110168", "K012197", "K090989", "K040056", "K081081", "K002079", "K941970", "K011388", "K091265", "K032051", "K955890", "K031987", "K072923", "K883341", "K150055", "K983307", "K033474", "K883344", "K972970", "K982025", "K033144", "K072596", "K010214", "K960329", "K001725", "K033275", "K062970", "K002806", "K011144", "K070455", "K964991", "K060934", "K141795", "K102496", "K091561", "K932028", "K120907", "K111693", "K051134", "K971148", "K983287", "K071025", "K082861", "K002232", "K142430", "K955828", "K042007", "K010634", "K853564", "K040404", "K010257", "K021453", "K062537" ], "pma_number": [ "P200005", "P160034", "P170018", "P160033", "P160028", "P160015", "P160022", "P180028", "P190013", "P160032", "P210015", "P160008", "P160026", "P200004", "P200007", "P160012", "P190007" ], "registration_number": [ "", "1720929", "3004906872", "3010839093", "3038259592", "3008717264", "3020460367", "3013500228", "3030446844", "3004123209", "3003521780", "1930027", "3014572985", "1320894", "3010030355", "3010317211", "3000126629", "1218058", "3002714378", "1423537", "8020045", "3009886119", "1317188", "3030733800", "3043226252", "3030677", "3013557562", "3010783192", "1223925", "3015876", "1921846", "3013826848", "3003537036", "1220908", "3027815", "3009077524", "3003867964", "3029871637", "3012972516", "9681860", "3005621729", "3002807314", "3026976873", "3003800159", "3015997711", "3012104670", "3017422354", "3011823740", "3014579161", "3005906887", "3007029079", "3026007685", "3004035727", "3015134086", "3013517171", "3021559257", "3012502601", "2132111", "3012607778", "1219103", "3012494290", "3013596024", "9681191", "3010703925", "1423662", "2112020", "3006108746" ], "fei_number": [ "", "1720929", "3004906872", "3010839093", "3038259592", "3008717264", "3020460367", "3013500228", "3030446844", "3004123209", "3003521780", "1930027", "3014572985", "3010030355", "3010317211", "3000126629", "1218058", "3002714378", "3009886119", "1317188", "3030733800", "3043226252", "3013557562", "3000215273", "3010783192", "1000148701", "3015876", "1921846", "3013826848", "3003537036", "1220908", "1000305720", "3009077524", "3003867964", "3003491392", "3029871637", "3012972516", "3001236905", "3005621729", "3002807314", "3026976873", "3001451571", "3003800159", "1000140026", "3015997711", "3012104670", "3017422354", "3011823740", "3014579161", "3005906887", "3007029079", "3026007685", "3004035727", "3015134086", "3013517171", "3021559257", "3012502601", "1000127185", "3012607778", "3012494290", "3013596024", "1000524572", "3010703925", "2112020", "3006108746", "6736", "3008207730" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }