Recall Z-0142-2027 ยท OBP Transcranial Magnetic Stimulator
Neuronetics, Inc.
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 Mob
| Date | Oct 9, 2026 (initiated Aug 24, 2026) |
| Status | Open, Classified |
| Reason | Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. |
| 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 |
| Quantity | 179 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan and South Korea. |
| FDA record | Open on fda.gov |