{ "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": "151125", "product_res_number": "Z-0761-2017", "event_date_initiated": "2010-03-11", "event_date_created": "2016-12-14", "recall_status": "Terminated", "event_date_terminated": "2016-12-16", "res_event_number": "75743", "product_code": "MKJ", "k_numbers": [ "K082937" ], "product_description": "The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical\npersonnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX", "code_info": "This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.", "firm_fei_number": "3015876", "recalling_firm": "Physio-Control, Inc.", "address_1": "11811 Willows Rd NE", "city": "Redmond", "state": "WA", "postal_code": "98052-2003", "additional_info_contact": "Rod J. Rylands\n425-867-4261", "reason_for_recall": "Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.", "root_cause_description": "Environmental control", "action": "Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.", "product_quantity": "1399 units (866 in the US and 533 outside US)", "distribution_pattern": "worldwide", "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" } } ] }