NeuroStar TMS Therapy System Upgrade Kit 3.0 USRecalls & reported problems
Neuronetics, Inc. · Class 2
All models of NeuroStar TMS Therapy System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Aug 24, 2026Open, Classified
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Z-0142-2027 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Transcranial Magnetic Stimulator devices
- NeuroStar TMS Therapy System NeuroStar 3.0 USNeuronetics, Inc. · Transcranial Magnetic Stimulator1 recall58 reports
- NeuroStar Advanced Therapy System Version 3.7Neuronetics, Inc. · Transcranial Magnetic Stimulator1 recall13 reports
- NeuroStar Advanced Therapy System Version 3.8Neuronetics, Inc. · Transcranial Magnetic Stimulator1 recall12 reports
- NeuroStar Advanced Therapy System Version 3.6Neuronetics, Inc. · Transcranial Magnetic Stimulator1 recall8 reports
- NeuroStar TMS Therapy System NeuroStar 2.0 USNeuronetics, Inc. · Transcranial Magnetic Stimulator1 recall2 reports
- Deep Transcranial Magnetic Stimulation (DTMS) System 104Brainsway Ltd · Transcranial Magnetic Stimulator5 reports
- NeuroStar Advanced Therapy System 3.XNeuronetics, Inc. · Transcranial Magnetic Stimulator3 reports
- NeuroStar Advanced Therapy System Version 3.7Neuronetics, Inc. · Transcranial Magnetic Stimulator1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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