{ "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": "86623", "product_res_number": "Z-0772-2010", "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 92531 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: 331327, 331014, 331000, 331317, 330984, 341805, 341827, 341306, 341912, 338527, 341683, 335085, 338117, 341312, 340263, 341818, 341820, 341821, 341791, 341890, 338113, 338059, 341944, 338039, 338041, 335057, 341348, 338084, 338053, 341782, 338060, 341923, 338073, 338075, 341316, 340255, 338050, 340365, 341787, 341732, 341729, 341726, 340354, 338078, 341717, 338916, 341882, 341703, 341263, 341706, 335258, 338142, 341877, 340312, 341780, 341778, 338217, 341836, 338940, 340338, 335140, 341884, 341755, 334495, 341750, 341749, 341891, 338035, 334402, 335413, 341497, 338024, 335457, 341966, 341534, 338002, 341518, 341430, 338017, 341511, 338027, 341548, 341566, 341567, 341542, 341434, 335449, 341549, 381727, 381729, 381724, 341888, 341806, 341901, 338079 and 341790.", "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": "94", "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", 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"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", 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} } ] }