{ "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": "37172", "product_res_number": "Z-0562-05", "event_date_initiated": "2005-02-03", "event_date_posted": "2005-03-10", "recall_status": "Terminated", "event_date_terminated": "2006-08-21", "res_event_number": "31111", "product_code": "MKJ", "product_description": "LIFEPAK 500 AED.", "code_info": "Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX", "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": "John A. Parks\n425-867-4681", "reason_for_recall": "Potential to not detect patients at the low end of the patient impedance range.", "root_cause_description": "Device Design", "action": "On 2/3/05 the firm issued a 'Medical Device Correction' letter dated January 2005 to their customers. The letter advised customers of the issue and stated a representative from the firm would visit each facility to update affected unit. On 2/25/05 a nationwide press release was issued. On 3/1/05 the firm began telephoning each customer, this was followed by another letter titled MEDICAL DEVICE RECALL. The letter advises of the issue and recommends defibrillators remain in service when no alternative is available until the unit can be corrected. Each unit will be replaced or corrected. On 4/22/05 the firm issued another letter, via certified mail return receipt, expanding their recall. Letter was issued to all customers affected by the expansion of the recall. On 4/22/05 the firm issued a press release advising of the expansion of the recall. The firm's web site also provides a listing of affected units.", "product_quantity": "2,349", "distribution_pattern": "Devices were distributed to 750 domestic consignees dn 16 international consignees.", "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" } } ] }