FDA-Device2026-10-21Class IIPROCESSING DEFECT
Neuronetics NeuroStar Advanced Therapy System recalled for coil assembly cable defect
What this means
Certain NeuroStar Advanced Therapy System units contain coil assembly cables that do not meet product specifications. The affected coil assemblies are identified by specific serial numbers. This defect could affect the device's performance or reliability during treatment.
- Check your device serial number against the recall list provided by Neuronetics.
- Contact Neuronetics or your healthcare provider if you have an affected system.
- Do not use the device until you have received guidance from Neuronetics or your provider.
The agency's original wording
Hazard
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
Affected count
179 units
Manufactured in
3222 Phoenixville Pike, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2027Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.