{ "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": "196113", "product_res_number": "Z-0118-2023", "event_date_initiated": "2022-09-22", "event_date_posted": "2022-10-21", "recall_status": "Open, Classified", "res_event_number": "90879", "product_code": "DRM", "k_numbers": [ "K112998" ], "product_description": "AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR", "code_info": "Model Number: 100\nUDI-DI Codes: (01)00849110\nPart Nos.\n12742-001\n12742-002\n12742-003\n12742-004\n12742-005\n12742-006\n12742-008\n12742-009\n12742-010\n12742-011\n12742-012\n12742-013\n12742-014\n12742-007\n12742-015\n12742-016\n12742-017\n12742-019\n\nSerial 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"firm_fei_number": "3003793491", "recalling_firm": "ZOLL Circulation, Inc.", "address_1": "2000 Ringwood Ave", "city": "San Jose", "state": "CA", "postal_code": "95131-1728", "additional_info_contact": "Hal Harmon\n408-419-2954", "reason_for_recall": "Due to increase in Li-Ion Battery failures", "root_cause_description": "Device Design", "action": "On 09/22/2022, the firm sent an \"MEDICAL DEVICE PRODUCT CORRECTION NOTICE\" via First Class Mail to customers informing them that ZOLL Circulation observed an increase in battery complaints of fully charged batteries no powering on the AutoPulse Platform. Investigations revealed that batteries stored at elevated temperatures were failing and are potentially due to a supplier switching to an alternate electrical component and thermal variation within specification of a second electrical component.\n\nCustomers are instructed to:\n1. Complete the Customer Acknowledgement/No-Charge Battery Replacement Request Form and email it to APBattery2022@zoll.com as soon as possible.\n2. While waiting for the replacement batteries to arrive, do not store the affected batteries in a hot environment prior to use such as in a hot vehicle, in the sun, or in a hot room. Storing the affected batteries in a hot environment may prevent the batteries from powering on the AutoPulse Platform. Note that the affected batteries will power on the AutoPulse Platform after they are allowed to cool.", "product_quantity": "6,353 batteries", "distribution_pattern": "U.S.: AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, RN, TX, UT, VA, VT, Virgin Islands, WA, WI, WV and WY.\n\nO.U.S.: United Arab Emirates, Austria, Australia, Azerbaijan, Brazil, Belarus, Canada, Switzerland, China, Costa Rica, Germany, Denmark, Egypt, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Moldova, Mexico, Malaysia, Netherlands, Norway, Panama, Philippines, Poland, Qatar, Romania, Russian, Saudi Arabia, Singapore, Slovenia, Taiwan, and Vietnam.", "openfda": { "k_number": [ "K024215", "K063602", "K072527", "K173553", "K112998", "K792451", "K962237", "K841410", "K062401", "K073079", "K811909", "K854734", "K761194", "K153628", "K011046", "K022345", "K792458", "K102068", "K855004", "K053403", "K801947", "K221700", "K851139", "K161768", "K801946", "K841275", "K811987", "K040453", "K790513", "K211289", "K792454", "K032852", "K090422", "K801945", "K922093", "K951124", "K792452", "K871272", "K972525", "K141809", "K871271", "K791145", "K841822", "K062119", "K833879" ], "registration_number": [ "3010030355", "3005445717", "3026976873", "3010703925", "3013964848", "3003521780", "3010617000", "3007275459", "3012972516", "3029871637", "3008727520", "1821850", "3015876" ], "fei_number": [ "3003793491", "3010030355", "3005445717", "3010703925", "3026976873", "3013964848", "3003521780", "3007275459", "3012972516", "3029871637", "3008727520", "1821850", "3015876" ], "device_name": "Compressor, Cardiac, External", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5200", "device_class": "2" } } ] }