Lower riskMedical device recall · FDA · Published August 24, 2026
NeuroStar Advanced Therapy System Recall: HP Coil Assembly Cables Not Conforming to Specs
Neuronetics recalls NeuroStar Advanced Therapy Systems with HP Coil Assembly Part Number 81-01000-200 due to cables not meeting product specifications. Affected units include specific models and software versions.
“NeuroStar Advanced Therapy System Recall: HP Coil Assembly Cables Not Conforming to Specs.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764823-neuronetics-inc-recalls-neurostar-advanced-therapy-system-contains-the-neurostar. Based on FDA recall #Z-0142-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0142-2027%22&limit=1).
The FDA announced on Aug. 24, 2026, that Neuronetics Inc. is recalling the NeuroStar Advanced Therapy System due to nonconforming cables in the HP Coil Assembly. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Neuronetics
Product: NeuroStar Advanced Therapy System
HP Coil Assembly Part Number: 81-01000-200
NeuroStar 2.0 US; Part Number: 81-01315-000
NeuroStar 3.0 US; Part Number: 81-02315-000
NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100
NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000
NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000
NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000
NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000
The hazard
The cables in the NeuroStar HP Coil Assembly are not in conformance with the product specifications required in production. The FDA said this defect affects 179 units distributed worldwide, including in the US, Japan, and South Korea.
Context
GovInfoNow's records show Neuronetics has had other recent recalls of similar products include Medtronic Octopus Nuvo Tissue Stabilizer Recall (2026-01-13), Medtronic Octopus 4 Tissue Stabilizer Model 29400 Recall (2026-05-12), and AVID Medical Halyard NEURO IR Peripheral Kit Recall (2026-03-13).
How to tell if you have this one
Check for the HP Coil Assembly Part Number 81-01000-200. Affected units include specific NeuroStar models (2.0 US, 3.0 US, Upgrade Kits, Mobile Consoles) with listed Part Numbers and UDI-DI codes.
Brand
Neuronetics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your NeuroStar system has the HP Coil Assembly Part Number 81-01000-200 and the listed coil serial numbers.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Japan and South Korea.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0142-2027 (August 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0142-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.