{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "32418", "product_res_number": "Z-0886-04", "event_date_initiated": "2004-04-02", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2005-01-06", "res_event_number": "28727", "product_code": "MKJ", "k_numbers": [ "K012428" ], "product_description": "LIFEPAK 500 automated external defibrillator", "code_info": "Part numbers 3005380-000 through 3005380-006 and 3005380-014 Serial numbers may be obtained from the firm or from Seattle District Recall Coordinator.  All battery date codes prior to 0013", "firm_fei_number": "3015876", "recalling_firm": "Medtronic Physio Control Corp", "address_1": "11811 Willows Rd NE", "city": "Redmond", "state": "WA", "postal_code": "98073", "additional_info_contact": "John A. Parks\n425-867-4681", "reason_for_recall": "Potential for batteries to malfunction due to battery cell rupture.", "root_cause_description": "Other", "action": "On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to customer.", "product_quantity": "7028", "distribution_pattern": "The firm distributed devices nationwide to various hospitals, medical centers, and businesses.\n\nThe firm also distributed to foreign customers in Australia, Argentina, Brazil, Canada, China, Greece, Hong Kong, Israel, India, Jordan, Mexico, Netherlands, New Zealand, Oman, Philippines, Saudi Arabia, United Kingdom.", "openfda": { "k_number": [ "K012766", "K072233", "K150198", "K991556", "K060559", "K091265", "K071025", "K111693", "K955890", "K110154", "K870622", "K932931", "K000638", "K942344", "K102972", "K020984", "K954609", "K972418", "K954504", "K142803", "K141774", "K073716", "K955882", "K082937", "K926172", "K003819", "K002806", "K091561", "K091943", "K883584", "K072596", "K070455", "K133659", "K991910", "K970741", "K022732", "K984286", "K110526", "K120406", "K011388", "K080232", "K021168", "K860676", "K113787", "K953204", "K112761", "K010918", "K062233", "K142915", "K110825", "K122758", "K102496", "K072812", "K121853", "K020203", "K090989", "K982264", "K032421", "K040056", "K954957", "K040479", "K002445", "K052465", "K013425", "K010214", "K993533", "K142430", "K031987", "K011901", "K990762", "K040256", "K982025", "K051134", "K972241", "K896919", "K010257", "K010634", "K091548", "K022929", "K021453", "K040404", "K063375", "K051076", "K014157", "K012030", "K033771", "K003565", "K131494", "K993072", "K123881", "K133484", "K022210", "K111594", "K081259", "K992977", "K012428", "K131525", "K011541", "K030898", "K033275", "K971149", "K040438", "K062970", "K080421", "K092598", "K131550", "K960329", "K020715", "K970719", "K991007", "K993036", "K133239", "K060934", "K061707", "K984582", "K932028", "K081828", "K992543", "K983307", "K112432", "K042417", "K940445", "K133269", "K072430", "K063510", "K143714", "K040775", "K853564", "K110978", "K033144", "K003548", "K072923", "K962359", "K892005", "K973486", "K883344", "K041067", "K981737", "K942850", "K991871", "K103186", "K081371", "K130684", "K965117", "K023854", "K042088", "K130454", "K981802", "K041459", "K990106", "K011144", "K042007", "K050004", "K964991", "K073089", "K130153", "K972970", "K980857", "K943698", "K892065", "K020288", "K052316", "K935922", "K013896", "K141795", "K014209", "K081081", "K033642", "K001725", "K092391", "K110742", "K971148", "K110361", "K080903", "K993745", "K042404", "K063119", "K100565", "K955828", "K141231", "K955854", "K120907", "K952101", "K032439", "K970391", "K941262", "K052057", "K032051", "K002232", "K040637", "K002079", "K882067", "K012197", "K002280", "K051475", "K934692", "K003228", "K031187", "K051632", "K925936", "K033896", "K062537", "K982992", "K010207", "K883341", "K052161", "K120536", "K120350", "K142709", "K033474", "K955923", "K110168", "K941970", "K955628", "K983393", "K103567", "K982710", "K062177", "K020743", "K133441", "K150055", "K041883", "K983287", "K122839", "K082090", "K041892", "K082861", "K122600" ], "pma_number": [ "P160022", "P160032", "P160033", "P190013", "P160015", "P170018", "P180028", "P160034", "P200007", "P200005", "P160028", "P160012", "P210015", "P160008", "P160026", "P190007", "P200004" ], "registration_number": [ "", "1320894", "3020460367", "3012104670", "3003521780", "3030446844", "3012972516", "3003867964", "3005621729", "1720929", "1220908", "3004906872", "3006108746", "3026976873", "3012502601", "3043226252", "3007029079", "3002807314", "3029871637", "1423662", "3004035727", "3021632375", "3009886119", "3003800159", "3015997711", "3013517171", "3017422354", "2112020", "3005906887", "3002714378", "3015134086", "3027815", "9681191", "1317188", "3010030355", "1930027", "3030733800", "3010783192", "3010703925", "3009077524", "3013826848", "3012494290", "3013596024", "3008717264", "3013500228", "8020045", "3038259592", "3011823740", "3012607778", "3030677", "1223925", "3003537036", "1423537", "3015876", "3013557562", "3026007685", "3014572985", "3021559257", "3010839093", "3004123209", "1921846", "3000126629", "1219103", "1218058", "3010317211", "9681860", "3014579161", "2132111" ], "fei_number": [ "", "3020460367", "3012104670", "3003521780", "3030446844", "3012972516", "3003867964", "3005621729", "1720929", "1220908", "3003491392", "1000524572", "3004906872", "3006108746", "3026976873", "3012502601", "3007029079", "1000148701", "3002807314", "3029871637", "6736", "3014579161", "3004035727", "3021632375", "3009886119", "3003800159", "3015997711", "3013517171", "3017422354", "2112020", "3005906887", "3002714378", "3015134086", "1317188", "3010030355", "1930027", "3030733800", "3010783192", "3010703925", "3009077524", "3013826848", "1000127185", "3001236905", "3012494290", "3001451571", "3013596024", "1000305720", "3008717264", "3013500228", "3038259592", "3011823740", "3012607778", "3003537036", "1218058", "3015876", "3013557562", "3026007685", "3014572985", "3021559257", "3010839093", "3004123209", "1921846", "3000126629", "3043226252", "3000215273", "3010317211", "3008207730", "1000140026" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }