{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Redmond", "state": "WA", "country": "United States", "classification": "Class I", "openfda": {}, "product_type": "Devices", "event_id": "81939", "recalling_firm": "Physio-Control Inc", "address_1": "11811 Willows Rd Ne", "address_2": "", "postal_code": "98052-2003", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "distribution_pattern": "Worldwide Distribution", "recall_number": "Z-0863-2019", "product_description": "LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.", "product_quantity": "682 kits", "reason_for_recall": "Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.", "recall_initiation_date": "20190201", "center_classification_date": "20190226", "termination_date": "20240418", "report_date": "20190306", "code_info": "Serial Numbers: 45902644 46103169 45987054 45953396 45483757 45477666 43251338 43251330 43251337 43251331 43251332 43258935 43258939 43258937 43228302 43228304 43228306 43232897 43233020 43232896 43232894 43247620 42916265 42806505 42798882 42798883 42798884 42792295 42798879 42792292 42792293 42792290 42769668 42769682 42769669 42769683 42769623 42769622 42769667 42682340 42682365 41927593 41927587 41927584 41927586 41927588 41927590 41917524 41909860 41909864 41909859 41917523 41909862 41917526 41909861 41909863 41704060 41675566 41675569 41675568 41675572 41675581 41675579 41664085 41664089 41659957 41280566 41280565 41271940 47605976 47605977 47605978 47605975 47452142 47154005 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