{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "78412", "product_res_number": "Z-1206-2009", "event_date_initiated": "2009-02-12", "event_date_posted": "2009-04-01", "recall_status": "Terminated", "event_date_terminated": "2026-04-09", "res_event_number": "51053", "product_code": "MKJ", "k_numbers": [ "K033474" ], "product_description": "Zoll AED Plus Defibrillator", "code_info": "Serial numbers below X_ _ _200000", "firm_fei_number": "1220908", "recalling_firm": "ZOLL Medical Corporation, World Wide Headquarters", "address_1": "269 Mill Rd", "city": "Chelmsford", "state": "MA", "postal_code": "01824", "additional_info_contact": "978-421-9655 Ext. 413", "reason_for_recall": "Device fails to discharge the defibrillation energy.", "root_cause_description": "Process design", "action": "On 3/31/09, the firm revised their recall strategy and required all users to a perform a \"Mandatory Upgrade\" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009.\n\nIn the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every three years. In lieu of replacing batteries every three years, customers will also have the choice to update their\ndevices with software that will monitor batteries for the identified defect. \n\n\n ZOLL will be send email notification to all consignees who have provided an email address as part of their contact information. ZOLL will also be publishing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/", "product_quantity": "183,535 units", "distribution_pattern": "Worldwide distribution", "openfda": { "k_number": [ "K954504", "K092598", "K022732", "K061707", "K143714", "K060559", "K072812", "K040256", "K011144", "K042404", "K993533", "K130153", "K021168", "K983287", "K040056", "K121853", "K003228", "K041883", "K091943", "K002280", "K033275", "K090989", "K013896", "K962359", "K892005", "K033771", "K992977", "K141231", "K002079", "K002806", "K942344", "K141774", "K030898", "K063375", "K012766", "K040438", "K940445", "K142803", "K040479", "K031987", "K123881", "K051134", "K983307", "K003565", "K860676", "K073089", "K032439", "K941262", "K020203", "K040637", "K042417", "K023854", "K050004", "K092391", "K003548", "K032421", "K131550", "K072430", "K955890", "K112432", "K020984", "K942850", "K062233", "K955923", "K883584", "K120406", "K926172", "K062537", "K131494", "K131525", "K110361", "K941970", "K130684", "K082090", "K882067", "K990762", "K040404", "K113787", "K972241", "K091548", "K122839", "K002445", "K002232", "K935922", "K062177", "K033896", "K133659", "K082937", "K020715", "K954957", "K980857", "K971148", "K033144", "K110978", "K111594", "K070455", "K020743", "K110742", "K072923", "K080903", "K103567", "K103186", "K041892", "K010207", "K081371", "K102496", "K033474", "K960329", "K970391", "K072596", "K142709", "K000638", "K012197", "K011388", "K955854", "K133239", "K041459", "K012030", "K062970", "K111693", "K112761", "K993072", "K060934", "K022210", "K081259", "K954609", "K981802", "K973486", "K052161", "K003819", "K110154", "K091561", "K014209", "K991556", "K870622", "K925936", "K883344", "K982264", "K001725", "K021453", "K970719", "K993745", "K892065", "K993036", "K063119", "K122600", "K012428", "K955882", "K031187", "K052465", "K142915", "K010257", "K934692", "K052057", "K120536", "K990106", "K982992", "K051076", "K955628", "K081081", "K122758", "K142430", "K120350", "K982710", "K133269", "K983393", "K133441", "K022929", "K051632", "K853564", "K091265", "K984286", "K042007", "K110168", "K972418", "K883341", "K011541", "K991871", "K080232", "K971149", "K063510", "K965117", "K082861", "K100565", "K041067", "K120907", "K052316", "K072233", "K033642", "K981737", "K932931", "K955828", "K010214", "K992543", "K051475", "K102972", "K130454", "K150055", "K014157", "K010918", "K010634", "K991910", "K970741", "K952101", "K110526", "K984582", "K150198", "K013425", "K080421", "K020288", "K972970", "K073716", "K991007", "K032051", "K040775", "K071025", "K943698", "K110825", "K141795", "K982025", "K953204", "K081828", "K133484", "K932028", "K964991", "K011901", "K042088", "K896919" ], "pma_number": [ "P200004", "P160012", "P160015", "P160034", "P200005", "P160026", "P160022", "P190007", "P160033", "P160008", "P160028", "P180028", "P200007", "P160032", "P190013", "P170018", "P210015" ], "registration_number": [ "3000126629", "3002807314", "3030677", "3005906887", "3049791233", "3015997711", "3027815", "3011823740", "3012972516", "1220908", "3003521780", "3009077524", "3012104670", "3010317211", "3043226252", "1223925", "2132111", "1423662", "3004906872", "3017422354", "3003537036", "3012607778", "3010783192", "3013557562", "3013517171", "3010030355", "3010703925", "3012494290", "8020045", "1423537", "1219103", "9681191", "9681860", "3004123209", "3013826848", "3005621729", "3007029079", "3006108746", "3026976873", "3030733800", "1317188", "3013596024", "3013500228", "3015876", "3015134086", "3003867964", "3009886119", "3008717264", "3026007685", "1720929", "3038259592", "3020460367", "3021632375", "3014579161", "3014572985", "1320894", "3002714378", "3021559257", "3004035727", "1930027", "1218058", "3012502601", "3003800159", "1921846", "3029871637", "2112020", "3030446844", "3010839093" ], "fei_number": [ "3000126629", "3002807314", "3001236905", "3005906887", "3049791233", "3015997711", "3003491392", "3011823740", "3012972516", "1220908", "1000305720", "3003521780", "3000215273", "3009077524", "3012104670", "3010317211", "3043226252", "3008207730", "3004906872", "1000148701", "3017422354", "3003537036", "3012607778", "3010783192", "3013557562", "3013517171", "3010030355", "3010703925", "3012494290", "3007029079", "3004123209", "3013826848", "3005621729", "3006108746", "3026976873", "3030733800", "1317188", "3013596024", "3013500228", "1000127185", "3015876", "3015134086", "3003867964", "1000140026", "3009886119", "3008717264", "1000524572", "1720929", "3038259592", "3020460367", "3021632375", "3014579161", "3026007685", "3014572985", "3002714378", "3021559257", "3004035727", "1930027", "6736", "3012502601", "3001451571", "1921846", "3029871637", "1218058", "3003800159", "2112020", "3030446844", "3010839093" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }