Home › COMMWELL RESEARCH & DEVELOPMENT LTD. › Commwell

Commwell

COMMWELL RESEARCH & DEVELOPMENT LTD. · Model RPCS5000 · UDI-DI 07290012672057

DXH Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.

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.