{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "50470", "product_res_number": "Z-0580-2007", "event_date_initiated": "2007-02-17", "event_date_posted": "2007-03-08", "recall_status": "Terminated", "event_date_terminated": "2021-06-09", "res_event_number": "37394", "product_code": "MKJ", "k_numbers": [ "K013896" ], "product_description": "Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)", "code_info": "Model DDU 100A-Software versions earlier than version 2.002", "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": "Brian Swan\n203-436-6654 Ext. 11", "reason_for_recall": "Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be \"unable\" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.", "root_cause_description": "Software design", "action": "Defibtech LLC initiated notification to customers/distributors on 2/17/07 by email. Hard copy letters followed on 2/22/07 with acknowledgement card. Users provided with instructions for 'Immediate Recommendations' until the unit''s software is upgraded.\n Distributors, their customers, and direct accounts instructed to locate affected units and upgrade these units in the field. Distributors, their\ncustomers, and direct accounts shall return to Defibtech documentation confirming unit\nsoftware upgrade was completed..Press was issued by the firm on March 6, 2007", "product_quantity": "22,197 units", "distribution_pattern": "Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.", "openfda": { "k_number": [ "K032439", "K971148", "K896919", "K992543", "K860676", "K983393", "K003565", "K040256", "K091561", "K031187", "K853564", "K030898", "K011144", "K103567", "K953204", "K955628", "K120406", "K111594", "K012766", "K002232", "K133484", "K150055", "K120536", "K993036", "K122600", "K020984", "K033771", "K993072", "K120907", "K060934", "K072430", "K110825", 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