{ "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": 1 } }, "results": [ { "cfres_id": "94386", "product_res_number": "Z-0077-2011", "event_date_initiated": "2010-08-27", "event_date_posted": "2010-10-18", "recall_status": "Terminated", "event_date_terminated": "2011-10-05", "res_event_number": "56729", "product_code": "MKJ", "k_numbers": [ "K013896" ], "product_description": "DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED).\nThe DDC-6-AA data card is an accessory to the AED and does not have its own intended use.", "code_info": "Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.", "firm_fei_number": "3003521780", "recalling_firm": "Defibtech, LLC", "address_1": "741 Boston Post Rd Ste 201 741 Boston Post Rd", "address_2": "Ste 201", "city": "Guilford", "state": "CT", "postal_code": "06437-2714", "additional_info_contact": "Al Raebuck\n203-453-6654 Ext. 122", "reason_for_recall": "Data cards may include an incorrect format which may cause the AED to not function correctly.", "root_cause_description": "Mixed-up of materials/components", "action": "Defibtech Initially notified customers by telephone on 8/27/10. Customers were notified of the product, the problem and the action to be taken. Customers were instructed to locate affected data cards and send them back to Defibtech for evaluation. If the data card was inserted into the AED, then the customer was instructed to check the AED software version. If the software version was at 2.005, the customer was instructed to keep the AED out of service until Defibtech could evaluate the returned data card. (Any other software version indicated that the device was not affected by a faulty data card). If the software version was any other version other than 2.005, then the customer was instructed to keep the AED in service unless the original service inquiry required it to remain out of service.\nIf the data card was not inserted into the AED, then the customer was instructed to return the data card for evaluation.\nFor any questions customers were to contact Customer Service at (866) 333-4241 from 8:30-5pm EST, M-F.", "product_quantity": "38", "distribution_pattern": "USA - Nationwide Distribution and Puerto Rico", "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", 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"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", 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"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" } } ] }