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CloudTMS

NEUROSOFT, OOO · Model CloudTMS · UDI-DI 04650075330296

OBP QCI Prescription

510(k) clearances

338

Adverse events (2 deaths)

Recalls

Facilities

Description

The CloudTMS 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. The Cloud TMS stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

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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Data 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.