Z-0142-2027

NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects...

Name: Z-0142-2027 NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects...
Creator: Neuronetics, Inc.
Published: 2026-08-24
License: https://open.fda.gov/license/

Neuronetics, Inc. / initiated 2026-08-24 / Open, Classified

FDA source

Recall record

Recall number: Z-0142-2027
Status: Open, Classified
Initiated: 2026-08-24
Posted: 2026-10-09
Recalling firm: Neuronetics, Inc.
Product: 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 code: OBP Transcranial Magnetic Stimulator
Reason for recall: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
FDA root cause: 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.
Quantity in commerce: 179 units
Distribution: Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
Product codes and lots: 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.

Product code OBP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)