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NeuroStar TMS Therapy System
NEURONETICS, INC. · Model NeuroStar 2.0 US · UDI-DI 00869378000100
OBP
Prescription
1
510(k) clearances
338
Adverse events (2 deaths)
5
Recalls
26
Facilities
Description
.
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.