NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number... recall (Neuronetics, Inc.)
Medical deviceClass IIOngoing
Summary: Neuronetics, Inc. is recalling 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; P. Reason: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
What is being recalled
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.
Why
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0142-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 24, 2026 |
| Reported | October 21, 2026 |
| Company | Neuronetics, Inc. |
| Company location | Malvern, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 179 units |
More recalls from Neuronetics, Inc. · all medical device recalls · recalls from August 2026