Home › NEUROSOFT, OOO › CloudTMS Edge
CloudTMS Edge
NEUROSOFT, OOO · Model Main unit · UDI-DI 04650075337783
OBP
Prescription
1
510(k) clearances
340
Adverse events (2 deaths)
5
Recalls
26
Facilities
Description
The CloudTMS Edge system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.