CloudEKG

NEUROSOFT, OOO · Model CloudEKG · UDI-DI 04650075330081

DXH Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals. Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology. The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals. CloudEKG can be 'used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings. All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.

Recalls

Date	Firm	Reason
2026-04-21	GE Medical Systems China Co., Ltd.	Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient.
2015-09-03	Spacelabs Healthcare Inc	When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. T
2015-01-09	Alivecor SFO	Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
2011-09-26	Lifewatch Services Inc	LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
2011-09-26	Lifewatch Services Inc	LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
2011-09-26	Lifewatch Services Inc	LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo

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 key Read the docs

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.