{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198895", "product_res_number": "Z-1312-2023", "event_date_initiated": "2023-02-14", "event_date_posted": "2023-03-30", "recall_status": "Open, Classified", "res_event_number": "91799", "product_code": "MKJ", "product_description": "DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest", "code_info": "UDI-DI: 00815098020003\nSerial Numbers:\n101702198\n101702263\n101702424\n101702524\n101702535\n101702540\n101702544\n101702545\n101703267\n101703269\n101703272\n101703274\n101703276\n101703277\n101703278\n101703281\n101703312\n101703326\n101703378\n101703407\n101703411\n101703412\n101703419\n101703424\n101703427\n101703464\n101703465\n101703600\n101704106", "firm_fei_number": "3003521780", "recalling_firm": "Defibtech, LLC", "address_1": "741 Boston Post Rd", "address_2": "Suite 201", "city": "Guilford", "state": "CT", "postal_code": "06437-2714", "additional_info_contact": "Defibtech Customer Service\n203-453-6654", "reason_for_recall": "A component of a sub-assembly used in the affected\nAEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.", "root_cause_description": "Device Design", "action": "Defibtech issued Urgent Medical Device Safety Removal User letter (FA2023-01) on 2/14/23 and 2/17/23 via email to Distributors and End-Users. Letter states reason for recall, health risk and action to take:\n1. Confirm receipt of this notice by checking the Read receipt option in the email notification containing this\ncommunication. Additionally, complete, sign and return to FA2023@defibtech.com the attached Receipt\nLetter acknowledging that you have received this recall notification\n2. Check the box label s 9-digit serial number of any units in your inventory against the serial numbers listed in\nthe attachment\n3. It is requested you quarantine the listed AEDs and Defibtech will contact you to arrange their return to\nDefibtech for screening\n4. If you have further transferred the device to another entity or department, you must provide this notice to\naffected parties\nPlease return any affected units as identified in the Attachment for replacement.\nDedicated support for handling all aspects of the return of identified units will be provided by Defibtech. We will be contacting you shortly to help you with the process and answer any questions. If you have questions now, please feel free to contact us using the email address FA2023@defibtech.com.\n Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.\n\nTo assure that you have received notification of this safety issue and understand your obligation in notifying those in possession of the serial number(s) shipped to you or on your behalf of any required action, please sign and return this letter to A2023@defibtech.com.", "product_quantity": "29 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K081371", "K110361", "K896919", "K941970", "K130454", "K031987", "K052057", "K120350", "K013896", "K020984", "K955628", "K943698", "K011388", "K142803", "K063375", "K033642", "K120406", "K062537", "K131525", "K032421", "K052161", "K041892", "K082090", "K993533", "K000638", "K882067", "K972241", "K012030", "K962359", "K984582", "K033896", "K040056", "K990106", "K012197", "K072430", "K992543", "K040438", "K072233", "K141774", "K141795", "K110154", "K133239", "K941262", "K942850", "K942344", "K103186", "K052465", "K002232", "K092391", "K990762", "K870622", "K021168", "K033275", 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