Recall Z-0142-2027— Neuronetics, Inc.

Name: FDA recall Z-0142-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-24

Class II · Ongoing

Class II FDA medical device recall by Neuronetics, Inc., initiated 2026-08-24. It names 2 FDA 510(k) clearances: K231926, K233621. 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..

Recalling firm: Neuronetics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-24
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K231926 — NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc.·cleared 2024-03-22
K233621 — NeuroStar Advanced Therapy System (Version 3.8)Neuronetics·cleared 2023-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Data sourced from openFDA. This site is unofficial and independent of the FDA.