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RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER

SHL TELEMEDICINE INTERNATIONAL LTD. · Model E-560-0 / E-561-0 · UDI-DI 07290008960267

DXH Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results.

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.