Rhythm Express

VIVAQUANT, INC. · Model RX-1 mini · UDI-DI 00860000272407

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network. The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

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

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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.