{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 334 } }, "results": [ { "cfres_id": "84415", "product_res_number": "Z-0003-2010", "event_date_initiated": "2009-08-21", "event_date_posted": "2009-11-09", "recall_status": "Terminated", "event_date_terminated": "2017-04-25", "res_event_number": "52990", "product_code": "MKJ", "k_numbers": [ "K031187" ], "product_description": "HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor.\n\nThe HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.", "code_info": "Serial numbers within the following range. US00533518 through US00535118.", "firm_fei_number": "1218950", "recalling_firm": "Philips Healthcare Inc.", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "SAME\n978-687-1501", "reason_for_recall": "incorrect default configuration settings, insufficient\nbattery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power", "root_cause_description": "Process change control", "action": "Philips Healthcare issued a Urgent Voluntary Medical Device Correction Notification on August 21, 2009 advising users of the problem and Customers are asked to follow the \"Action to be taken by customer/user\" section of the Urgent\nVoluntary Medical Device Correction Notification. In this section, customers are given the instructions to correct their devices. For further information or support concerning this issue, please contact Philips representative at 1-800-722-9377.", "product_quantity": "1,523 units", "distribution_pattern": "Nationwide\nCanada\nAustralia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar,\nRussia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK", "openfda": { "k_number": [ "K970741", "K883344", "K142803", "K954504", "K955923", "K141231", "K072923", "K981737", "K032051", "K982710", "K860676", "K111693", "K003565", "K981802", "K972241", "K122839", "K110825", "K992543", "K142915", "K150198", "K014157", "K091265", "K062233", "K042007", "K091561", "K012197", "K081371", "K012766", "K110168", "K954609", "K990106", "K020203", "K002079", "K001725", "K002445", "K971148", "K072430", "K080232", "K031187", "K081828", "K051475", "K110742", "K010634", "K980857", "K052465", "K970391", "K142430", "K964991", "K983393", "K123881", "K130454", "K040637", "K010257", "K020984", "K993072", "K022732", "K033474", "K131494", "K002232", "K984286", "K143714", "K992977", "K040056", "K002806", "K073089", "K942850", "K072596", "K990762", "K011901", "K033144", "K120350", "K984582", "K082937", "K943698", "K070455", "K013896", "K052161", "K040404", "K102972", "K110526", "K940445", "K002280", "K041459", "K110361", "K063375", "K133659", "K870622", "K040438", "K052057", "K141774", "K112432", "K014209", "K962359", "K063510", "K103186", "K883341", "K955828", "K932931", "K051632", "K882067", "K122600", "K141795", "K973486", "K050004", "K040479", "K020288", "K060559", "K926172", "K965117", "K970719", "K042417", "K960329", "K052316", "K020715", "K062537", "K041883", "K983287", "K110978", "K133269", "K982025", "K073716", "K103567", "K982992", "K000638", "K021168", "K892065", "K972418", "K953204", "K955628", "K062970", "K080903", "K120406", "K991910", "K991007", "K030898", "K033771", "K993745", "K883584", "K131525", "K003548", "K092391", "K993533", "K991556", "K991871", "K071025", "K020743", "K853564", "K072812", "K150055", "K100565", "K112761", "K003228", "K012428", "K023854", "K011541", "K892005", "K941262", "K040775", "K091548", "K954957", "K952101", "K130153", "K013425", "K955882", "K942344", "K130684", "K041067", "K032439", "K051134", "K972970", "K033896", "K934692", "K932028", "K955890", "K061707", "K012030", "K031987", "K941970", "K971149", "K051076", "K121853", "K010214", "K993036", "K040256", "K032421", "K935922", "K091943", "K072233", "K082861", "K063119", "K120907", "K082090", "K113787", "K131550", "K010207", "K955854", "K060934", "K011144", "K041892", "K062177", "K982264", "K090989", "K081081", "K021453", "K022210", "K111594", "K042404", "K120536", "K925936", "K010918", "K033275", "K133484", "K142709", "K102496", "K983307", "K133239", "K092598", "K122758", "K081259", "K042088", "K133441", "K896919", "K011388", "K003819", "K033642", "K022929", "K080421", "K110154" ], "pma_number": [ "P160032", "P190013", "P160034", "P160008", "P190007", "P180028", "P200007", "P160012", "P170018", "P210015", "P200005", "P160022", "P160033", "P200004", "P160028", "P160015", "P160026" ], "registration_number": [ "", "1423537", "9681191", "3030733800", "3002807314", "3004035727", "3012494290", "3002714378", "3029871637", "3026007685", "3009077524", "3012502601", "3014579161", "3043226252", "3013517171", "1218058", "3003521780", "1921846", "3012972516", "3038259592", "3013826848", "3003537036", "3005621729", "3014572985", "1223925", "3006108746", "2112020", "1423662", "3008717264", "8020045", "3030446844", "3026976873", "3010317211", "3021559257", "9681860", "3004906872", "3010783192", "3020460367", "3010839093", "3030677", "3013596024", "3012104670", "3005906887", "3027815", "3015876", "3013557562", "3003800159", "3017422354", "3009886119", "3010030355", "3003867964", "1219103", "1317188", "1320894", "1720929", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3015997711", "2132111", "3012607778", "3010703925", "3004123209", "3015134086", "3007029079" ], "fei_number": [ "", "3030733800", "3002807314", "3004035727", "3012494290", "3002714378", "3029871637", "3026007685", "3009077524", "3012502601", "1000524572", "3001451571", "3014579161", "1000305720", "3043226252", "3013517171", "1218058", "3001236905", "3003521780", "1000148701", "1921846", "3012972516", "3038259592", "3013826848", "3003537036", "3005621729", "3014572985", "3006108746", "2112020", "3008717264", "3008207730", "3030446844", "3026976873", "3010317211", "3021559257", "1000127185", "3004906872", "6736", "3010783192", "3020460367", "3010839093", "3000215273", "3012104670", "3013596024", "3005906887", "1000140026", "3015876", "3013557562", "3003800159", "3017422354", "3009886119", "3010030355", "3003867964", "1317188", "1720929", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3003491392", "3015997711", "3012607778", "3010703925", "3004123209", "3015134086", "3007029079" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }