{ "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": "44986", "product_res_number": "Z-0710-06", "event_date_initiated": "2006-03-22", "event_date_posted": "2006-04-04", "recall_status": "Terminated", "event_date_terminated": "2011-09-06", "res_event_number": "34947", "product_code": "MKJ", "k_numbers": [ "K010918" ], "product_description": "LIFEPAK 12 defibrillator/monitor", "code_info": "Domestic Serial Numbers: 34106383, 33996555, 33992033, 33992030, 33992029, 33992031, 33992027, 33990244, 33990241, 33990245, 33990242, 33990240, 34096406, 34086957, 34039438, 34100891, 33917921, 34100498, 34019560, 34011939, 34011940, 33985062, 33985063, 33985064, 33985065, 33985066, 33985067, 33985068, 33985070, 33985069, 33985074, 33985061, 33985071, 33985073, 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34039417, 34003928, 34004922, 34004924, 34039423, 33968959, 34106425, 34106224, 34106225, 34086724, 34091392, 34086725.", "firm_fei_number": "3015876", "recalling_firm": "Medtronic Emergency Response Systems, Inc.", "address_1": "11811 Willows Rd Ne", "city": "Redmond", "state": "WA", "postal_code": "98052-2003", "additional_info_contact": "Todd Bandy\n425-867-4514", "reason_for_recall": "Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.", "root_cause_description": "Nonconforming Material/Component", "action": "On 3/22/06, the firm began sending out letters dated March 2006, and flagged URGENT MEDICAL DEVICE CORRECTION. The letters advised customers of the issue and that a service representative would visit and inspect the therapy connector sockets, and replace the therapy connector and the mating cable if short drill sockets are found.", "product_quantity": "942 devices", "distribution_pattern": "Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,", "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" } } ] }