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Class IIOngoing

Neuronetics, Inc. recalls NeuroStar Advanced Therapy System

Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Neuronetics, Inc.
Reason
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99812…

Products

  1. 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.

    Codes/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 NumberQuantity: 179 unitsRecall no. Z-0142-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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