United StatesWhat's 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.
Recalling firm: Neuronetics, Inc., Malvern, PA, United States.
How to identify it
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…
The hazard
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)