{ "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": "95038", "product_res_number": "Z-0625-2011", "event_date_initiated": "2010-09-24", "event_date_posted": "2010-12-16", "recall_status": "Terminated", "event_date_terminated": "2012-07-05", "res_event_number": "56957", "product_code": "MVK", "pma_numbers": [ "P010030" ], "product_description": "Model 4000 Monitor component of the LifeVest Wearable Defibrillator", "code_info": "product number 10A0988-A01; Serial number: 07000178, 07000196, 07000199, 07000202, 07000205, 07000211, 07000214, 07000223, 07000232, 07000241, 07000250, 07000265, 07000271, 07000289, 07000298, 07000301, 07000304, 07000307, 07000310, 07000313, 07000316, 07000325, 07000337, 07000343, 07000349, 07000355, 07000361, 07000373, 07000388, 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intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.", "root_cause_description": "Other", "action": "Zoll Life Vest contacted patients that are expected to be in the device more than 60 days by letter and phone to arrange replacement monitors. Instructions for the return of the recalled monitor accompany the replacement monitor The firm will also contact the prescribing physician via telephone for long-term use patients to inform the physician of this voluntary recall and to assist in contacting any patients the firm was unable to reach by telephone.\nZoll Life Vest can be contacted at 1-800-543-3267 about this recall.", "product_quantity": "494 units", "distribution_pattern": "Nationwide Distribution: Throughout the US. including the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV.", "openfda": { "pma_number": [ "P230022", "P010030", "P200037" ], "registration_number": [ "3027605722", "1927395", "2031044", "3015185344", "1220908", "1930027", "2133641", "3008642652", "2135338", "1218058" ], "fei_number": [ "1218058", "3027605722", "3005700659", "1927395", "3015185344", "3001236763", "1220908", "1930027", "3008642652", "3000203466" ], "device_name": "Wearable Automated External Defibrillator", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }