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NeuroStar Head Support System, Domestic
NEURONETICS, INC. · Model 81-04836-00U · UDI-DI 00850005944898
OBP
Prescription
1
510(k) clearances
340
Adverse events (2 deaths)
5
Recalls
26
Facilities
Description
The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and treatment processes. NeuroStar Head Support System, Domestic, Demo.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-23 | The Magstim Company Limited | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail. |
| 2020-03-23 | The Magstim Company Limited | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail. |
| 2018-10-25 | The Magstim Company Limited | A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm. |
| 2017-09-28 | The Magstim Company Limited | Users manuals not supplied with 4800-00T US Rapid Therapy System |
| 2009-03-16 | Neuronetics, Inc. | SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heatin |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.