{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "85733", "product_res_number": "Z-0062-2010", "event_date_initiated": "2009-10-01", "event_date_posted": "2009-12-08", "recall_status": "Terminated", "event_date_terminated": "2013-09-27", "res_event_number": "53383", "product_code": "MKJ", "k_numbers": [ "K051632" ], "product_description": "Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. \nModel M3861A is under the Philips label and M3841A is under the Laerdal label.", "code_info": "The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and  AC4=Portugal.  Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems", "address_1": "2301 5th Ave Ste 200 2301 5th Ave", "address_2": "Ste 200", "city": "Seattle", "state": "WA", "postal_code": "98121", "additional_info_contact": "George Biggins\n206-664-5215", "reason_for_recall": "A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.", "root_cause_description": "Nonconforming Material/Component", "action": "On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool.\n\nFor further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.", "product_quantity": "see Z-0063-2010", "distribution_pattern": "Domestic and Worldwide distribution to:\nUnited States, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates.", "openfda": { "k_number": [ "K102496", "K010214", "K011901", "K130684", "K000638", "K110742", "K003565", "K984582", "K896919", "K002232", "K150055", "K990106", "K131550", "K973486", "K133659", "K051632", "K883341", "K020984", "K041883", "K932028", "K991007", "K052316", "K870622", "K103186", "K991910", "K955854", "K965117", "K934692", "K020743", "K010207", "K980857", "K131525", "K142430", "K981737", "K002806", "K014157", "K952101", "K063375", "K022929", "K142709", "K111693", "K011541", "K051475", "K981802", "K060934", "K892005", "K982992", "K012030", "K010257", "K942344", "K925936", "K012766", "K002445", "K013425", "K040479", "K062970", "K942850", "K133441", "K072233", "K051076", "K091265", "K082861", "K003819", "K040775", "K061707", "K063119", "K033275", "K031187", "K990762", "K082937", "K052057", "K142915", "K853564", "K970719", "K130153", "K072430", "K071025", "K010634", "K080421", "K955890", "K091561", "K040256", "K962359", "K033144", "K040438", "K033771", "K102972", "K081259", "K120907", "K954957", "K073716", "K014209", "K110825", "K121853", "K955828", "K983287", "K983393", "K991556", "K040404", "K001725", "K984286", "K063510", "K110978", "K955882", "K002280", "K150198", "K133269", "K032421", "K941262", "K070455", "K011144", "K050004", "K941970", "K092598", "K122758", "K021453", "K103567", "K012428", "K982264", "K991871", "K032051", "K971149", "K130454", "K042088", "K992977", "K120350", "K120406", "K992543", "K080232", "K051134", "K040637", "K052465", "K112432", "K013896", "K972970", "K993745", "K983307", "K012197", "K926172", "K052161", "K003548", "K032439", "K964991", "K943698", "K133239", "K041067", "K940445", "K122839", "K073089", "K110526", "K993533", "K080903", "K023854", "K110361", "K113787", "K971148", "K970391", "K110154", "K041459", "K033642", "K072923", "K062177", "K072812", "K122600", "K141795", "K020203", "K040056", "K042417", "K081828", "K972418", "K955628", "K100565", "K033474", "K993072", "K970741", "K042404", "K092391", "K954504", "K062537", "K955923", "K892065", "K960329", "K932931", "K030898", "K002079", "K011388", "K954609", "K022732", "K091943", "K081371", "K091548", "K131494", "K003228", "K020715", "K972241", "K982710", "K860676", "K883344", "K082090", "K042007", "K142803", "K993036", "K031987", "K022210", "K090989", "K041892", "K111594", "K010918", "K033896", "K120536", "K020288", "K060559", "K141774", "K081081", "K062233", "K882067", "K935922", "K110168", "K072596", "K953204", "K141231", "K021168", "K123881", "K143714", "K112761", "K133484", "K883584", "K982025" ], "pma_number": [ "P160034", "P210015", "P200004", "P170018", "P190013", "P160022", "P180028", "P190007", "P200007", "P160008", "P200005", "P160012", "P160015", "P160026", "P160028", "P160032", "P160033" ], "registration_number": [ "", "3013826848", "3010703925", "8020045", "1219103", "3030446844", "3005621729", "3020460367", "3004906872", "3012494290", "3012502601", "3012607778", "3015134086", "3010030355", "1720929", "3021559257", "3026976873", "3012104670", "3013500228", "1320894", "2112020", "3009077524", "3015876", "3014579161", "3029871637", "3030677", "3002807314", "3003537036", "1423537", "3010317211", "1921846", "2132111", "3027815", "1220908", "9681191", "3006108746", "3004123209", "3008717264", "3011823740", "3017422354", "3030733800", "3015997711", "3005906887", "3004035727", "1423662", "3038259592", "3003800159", "1930027", "3009886119", "3013557562", "3003867964", "3010839093", "9681860", "3010783192", "3012972516", "3026007685", "1223925", "3013596024", "3043226252", "3003521780", "1317188", "3002714378", "3007029079", "3000126629", "3013517171", "3014572985", "1218058" ], "fei_number": [ "1000524572", "", "3013826848", "3010703925", "1000305720", "3030446844", "3005621729", "3020460367", "3004906872", "3012494290", "3012502601", "3012607778", "3015134086", "3001451571", "3010030355", "1720929", "3021559257", "3026976873", "3012104670", "1000127185", "3013500228", "2112020", "3009077524", "3015876", "3014579161", "3029871637", "3002807314", "3003537036", "3010317211", "1921846", "1220908", "6736", "3006108746", "3004123209", "3008717264", "3011823740", "3017422354", "3030733800", "3015997711", "3005906887", "3000215273", "3004035727", "3003491392", "3008207730", "3038259592", "3001236905", "3003800159", "1930027", "3009886119", "3013557562", "3003867964", "3010839093", "3010783192", "3012972516", "3026007685", "1000140026", "1000148701", "3013596024", "3043226252", "3003521780", "1317188", "3002714378", "3007029079", "3000126629", "3013517171", "3014572985", "1218058" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }