{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "36423", "product_res_number": "Z-0398-05", "event_date_initiated": "2004-11-12", "event_date_posted": "2005-01-15", "recall_status": "Terminated", "event_date_terminated": "2006-06-25", "res_event_number": "30704", "product_code": "MKJ", "k_numbers": [ "K031987" ], "product_description": "Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.", "code_info": "Model no. 9300E serial numbers: 360814 thru 361239, 361320 thru 362359, 362387 thru 362393, 362396 thru 362713, 362916 thru 364194, 364283 thru 364514, and 364606 thru 364914.", "firm_fei_number": "2112020", "recalling_firm": "Cardiac Science, Inc.", "address_1": "5474 Feltl Rd", "city": "Minnetonka", "state": "MN", "postal_code": "55343-7982", "additional_info_contact": "Mac McKeen\n952-939-2911", "reason_for_recall": "AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.", "root_cause_description": "Nonconforming Material/Component", "action": "Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.", "product_quantity": "2049", "distribution_pattern": "Throughout the United States, Canada and Europe.", "openfda": { "k_number": [ "K032439", "K971148", "K896919", "K992543", "K860676", "K983393", "K003565", "K040256", "K091561", "K031187", "K853564", "K030898", "K011144", "K103567", "K953204", "K955628", "K120406", "K111594", "K012766", "K002232", "K133484", "K150055", "K120536", "K993036", "K122600", "K020984", "K033771", "K993072", "K120907", "K060934", "K072430", "K110825", "K063510", "K041067", "K111693", "K130684", "K010214", "K063119", "K091265", "K123881", "K962359", "K932931", "K062177", "K942850", "K092598", "K943698", "K002445", "K142430", "K143714", "K955923", "K080421", "K040438", "K120350", "K935922", "K061707", "K012428", "K980857", "K003548", "K141774", "K040404", "K990762", "K112432", "K991556", "K954957", "K122839", "K100565", "K011901", "K052057", "K113787", "K040637", "K002806", "K081081", "K964991", "K041883", "K090989", "K072812", "K022732", "K934692", "K062537", "K062970", "K032051", "K133441", "K882067", "K082937", "K955828", "K133269", "K970391", "K992977", "K142915", "K942344", "K940445", "K001725", "K131494", "K991007", "K022210", "K973486", "K051134", "K041459", "K022929", "K990106", "K052161", "K002280", "K926172", "K081259", "K993745", "K955882", "K981802", "K991910", "K072233", "K033474", "K073716", "K011541", "K060559", "K954504", "K981737", "K991871", "K070455", "K972418", "K883344", "K955890", "K040479", "K003228", "K141795", "K954609", "K010634", "K012197", "K033642", "K062233", "K131550", "K040056", "K110154", "K925936", "K982710", "K972970", "K941262", "K142803", "K984582", "K883584", "K133239", "K970719", "K021168", "K052465", "K971149", "K131525", "K020743", "K952101", "K003819", "K972241", "K033275", "K002079", "K012030", "K051076", "K102972", "K014157", "K892005", "K072596", "K011388", "K112761", "K970741", "K965117", "K052316", "K010918", "K982264", "K051632", "K080903", "K141231", "K080232", "K110361", "K122758", "K870622", "K932028", "K010207", "K031987", "K010257", "K021453", "K020288", "K050004", "K020715", "K982992", "K071025", "K121853", "K983287", "K013896", "K091548", "K110978", "K081371", "K082090", "K130454", "K955854", "K982025", "K042404", "K040775", "K103186", "K892065", "K110742", "K133659", "K081828", "K063375", "K983307", "K072923", "K130153", "K110168", "K042007", "K092391", "K142709", "K041892", "K150198", "K033144", "K082861", "K020203", "K960329", "K042417", "K013425", "K091943", "K033896", "K941970", "K102496", "K110526", "K042088", "K073089", "K000638", "K032421", "K883341", "K984286", "K014209", "K023854", "K993533", "K051475" ], "pma_number": [ "P160032", "P210015", "P200007", "P160033", "P160015", "P160022", "P160012", "P160008", "P190007", "P200004", "P190013", "P200005", "P160026", "P170018", "P160028", "P160034", "P180028" ], "registration_number": [ "3030733800", "", "3026007685", "3003867964", "3013517171", "2132111", "1220908", "3020460367", "3010783192", "3003800159", "3010703925", "3012494290", "2112020", "3010839093", "3015997711", "1720929", "3004123209", "3017422354", "3004035727", "3026976873", "3005906887", "1317188", "3015134086", "3012104670", "3000126629", "3043226252", "3013500228", "1219103", "3004906872", "3003537036", "3014572985", "1423537", "3011823740", "1423662", "3021559257", "3010030355", "3012972516", "3005621729", "3038259592", "3029871637", "3007029079", "3013596024", "3008717264", "1930027", "3010317211", "3013826848", "3012607778", "3030446844", "3030677", "1218058", "3027815", "3002807314", "9681860", "3009077524", "9681191", "1320894", "3013557562", "3009886119", "1223925", "3003521780", "3002714378", "3006108746", "3014579161", "8020045", "1921846", "3012502601", "3015876" ], "fei_number": [ "3030733800", "", "3026007685", "3003867964", "3013517171", "3007029079", "1220908", "3020460367", "3010783192", "3003800159", "3010703925", "3012494290", "2112020", "3010839093", "3001236905", "3015997711", "3004123209", "1720929", "3017422354", "3004035727", "3026976873", "3005906887", "1317188", "3015134086", "3012104670", "3000126629", "3043226252", "1000127185", "6736", "3013500228", "3003537036", "3004906872", "3014572985", "3011823740", "3021559257", "3010030355", "3012972516", "3005621729", "3038259592", "1000305720", "3029871637", "3013596024", "3008717264", "3003491392", "3010317211", "3013826848", "3012607778", "1930027", "1000140026", "3030446844", "3000215273", "1218058", "3002807314", "3009077524", "3013557562", "3009886119", "3003521780", "3002714378", "3006108746", "1000524572", "3014579161", "1921846", "3001451571", "1000148701", "3008207730", "3012502601", "3015876" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }