{
  "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": "2026-10-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99812",
      "recalling_firm": "Neuronetics, Inc.",
      "address_1": "3222 Phoenixville Pike",
      "address_2": "",
      "postal_code": "19355-9615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Japan and South Korea.",
      "recall_number": "Z-0142-2027",
      "product_description": "NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:    1. NeuroStar 2.0 US; Part Number: 81-01315-000.     2. NeuroStar 3.0 US; Part Number: 81-02315-000.     3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100.     4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000.     5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000.     6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000.     7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000.",
      "product_quantity": "179 units",
      "reason_for_recall": "Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.",
      "recall_initiation_date": "20260824",
      "center_classification_date": "20261009",
      "report_date": "20261021",
      "code_info": "NeuroStar Software Versions 3.6, 3.7, 3.8   1. NeuroStar 2.0 US; Part Number: 81-01315-000; UDI-DI: 00869378000100.   2. NeuroStar 3.0 US; Part Number: 81-02315-000; UDI-DI: 00869378000117.   3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100; UDI-DI: 00869378000193.   4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000; UDI-DI: 00869378000155.   5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000; UDI-DI: 00850005944058.   6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000; UDI-DI: 00850005944522.   7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000; UDI-DI: 00850005944621.   NeuroStar 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.",
      "more_code_info": ""
    }
  ]
}