Neuronetics, Inc.: Transcranial Magnetic Stimulator
- 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.
- Reason
- Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5d5ff663-bb6a-4fa9-8712-a8ebfc3d6fde