# Class II recall Z-0142-2027: Neuronetics, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0142-2027 |
| Recalling firm | Neuronetics, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 |
| Reason | Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. |
| Quantity | 179 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan and South Korea. |
| Recall initiated | 2026-08-24 |
| Reported | 2026-10-21 |
| Firm location | Malvern, PA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0142-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.