{ "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": "2026-10-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222521", "product_res_number": "Z-0142-2027", "event_date_initiated": "2026-08-24", "event_date_posted": "2026-10-09", "recall_status": "Open, Classified", "res_event_number": "99812", "product_code": "OBP", "k_numbers": [ "K231926", "K233621" ], "product_description": "NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:\r\n\r\n1. NeuroStar 2.0 US; Part Number: 81-01315-000. \r\n\r\n2. NeuroStar 3.0 US; Part Number: 81-02315-000. \r\n\r\n3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100. \r\n\r\n4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000. \r\n\r\n5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000. \r\n\r\n6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000. \r\n\r\n7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000.", "code_info": "NeuroStar Software Versions 3.6, 3.7, 3.8 \n\n1. NeuroStar 2.0 US; Part Number: 81-01315-000; UDI-DI: 00869378000100. \n\n2. NeuroStar 3.0 US; Part Number: 81-02315-000; UDI-DI: 00869378000117. \n\n3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100; UDI-DI: 00869378000193. \n\n4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000; UDI-DI: 00869378000155. \n\n5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000; UDI-DI: 00850005944058. \n\n6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000; UDI-DI: 00850005944522. \n\n7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000; UDI-DI: 00850005944621. \n\nNeuroStar HP Coil Assembly Part Number: 81-01000-200. Coil Serial Numbers: 40203, 40208, 40202, 40204, 40206, 40205, 40207, 40209, 40210, 40211, 40212, 40213, 40214, 40215, 40216, 40217, 40218, 40219, 40220, 40221, 40222, 40223, 40224, 40225, 40227, 40228, 40226, 40229, 40230, 40231, 40232, 40233, 40234, 40236, 40235, 40238, 40239, 40240, 40241, 40242, 40243, 40244, 40245, 40246, 40247, 40248, 40249, 40250, 40251, 40252, 40253, 40254, 40255, 40256, 40257, 40258, 40259, 40260, 40261, 40262, 40263, 40265, 40266, 40267, 40264, 40283, 40284, 40285, 40286, 40287, 40288, 40289, 40290, 40291, 40293, 40292, 40294, 40295, 40296, 40297, 40298, 40299, 40300, 40301, 40302, 40303, 40304, 40305, 40306, 40307, 40308, 40309, 40310, 40311, 40312, 40313, 40314, 40315, 40316, 40317, 40318, 40320, 40319, 40321, 40322, 40323, 40324, 40325, 40326, 40327, 40328, 40329, 40331, 40332, 40333, 40334, 40335, 40336, 40337, 40338, 40339, 40340, 40341, 40342, 40343, 40344, 40347, 40346, 40345, 40348, 40349, 40350, 40353, 40352, 40351, 40354, 40355, 40356, 40357, 40358, 40359, 40360, 40371, 40372, 40373, 40374, 40375, 40376, 30643, 40274, 30638, 40281, 40199, 30671, 40201, 40272, 30641, 40278, 30646, 30653, 30640, 30647, 30652, 40275, 30648, 40197, 40279, 30650, 30639, 30623, 40198, 40280, 40270, 30645, 30654, 30636, 40200, 30635, 40282, 30606, 30607, 30608, 30609, 30610, 30611, 30624, 30625, 30630, 30631, 30632, 30633, 30634, 30655, 30656, 30657, 30658, 30659, 30660, 30622, 30621, 30626, 30614, 30620, 30616, 30619, 30615, 30617, 30661, 30662, 30663, 30664, 30665, 30627, 30628, 30629, 30644, 40268, 40269.", "firm_fei_number": "3004824012", "recalling_firm": "Neuronetics, Inc.", "address_1": "3222 Phoenixville Pike", "city": "Malvern", "state": "PA", "postal_code": "19355-9615", "additional_info_contact": "Alexandra Williamson\n610-640-4202", "reason_for_recall": "Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.", "root_cause_description": "Nonconforming Material/Component", "action": "NeuroStar began notification to consignees on about 08/24/2026 via email. Consignees were instructed to check their NeuroStar System for Console and Coil for affected serial numbers and complete and return the response form. A NeuroStar Field Service Engineer will contact you to coordinate product inspection at no expense to you. If the HP Coild Assembly is not affected, no action is required. If it is determined the product is nonconforming, the affected product will be replaced with a HP Coil Assembly with the proper specifications to address the issue at no expense to you. The Field Service Engineer will handle the delivery and installation of the HP Coil Assembly and return of the affected coil. The actions are expected to be completed in the next 12 months.", "product_quantity": "179 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Japan and South Korea.", "openfda": { "k_number": [ "K220177", "K260560", "K251125", "K173441", "K251119", "K083538", "K183376", "K143531", "K171967", "K222230", "K233621", "K182700", "K220127", "K133408", "K173540", "K253098", "K232235", "K220819", "K180907", "K171902", "K241518", "K180313", "K130233", "K171481", "K222171", "K232639", "K231926", "K252032", "K160309", "K212723", "K230735", "K243869", "K243319", "DEN070003", "K171051", "K251391", "K150641", "K243539", "K251449", "K223154", "K210201", "K201158", "K233631", "K211389", "K260691", "K260189", "K173620", "K220625", "K182853", "K232688", "K230029", "K202537", "K243460", "K261228", "K243700", "K160703", "K213543", "K251653", "K252358", "K161519", "K260396", "K203735", "K251210", "K250689", "K170114", "K162935", "K222196", "K122288", "K172667" ], "registration_number": [ "8021774", "3029464335", "3031980484", "3003127839", "3045753434", "9612389", "3007147067", "3017496797", "3035374386", "3029767018", "3005545216", "3008881376", "3019055598", "3006418479", "3014251656", "3012352782", "3012823347", "3014680784", "3004824012", "3005205657", "3020848550", "3010300912", "3003144120", "3039167582", "3018708317", "3005268307" ], "fei_number": [ "3029464335", "3031980484", "3003127839", "3002808356", "3045753434", "3007147067", "3017496797", "3035374386", "3029767018", "3005545216", "3008881376", "3019055598", "3006418479", "3014251656", "3004099094", "3012352782", "3012823347", "3004824012", "1825560", "3005205657", "3020848550", "3010300912", "3003255845", "3039167582", "3018708317", "3005268307" ], "device_name": "Transcranial Magnetic Stimulator", "medical_specialty_description": "Neurology", "regulation_number": "882.5805", "device_class": "2" } } ] }