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Eko Analysis Software

Eko Devices, Inc. · Model EAS · UDI-DI 00850010298030

MWI DPS DQD Prescription

510(k) clearances

2,065

Adverse events (45 deaths)

Recalls

174

Facilities

Description

The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)

Recalls

Date	Firm	Reason
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-10	GE Medical Systems Information Technologies Inc	Portrait Core Services Software version V1.2.0 Security Vulnerability
2026-01-30	Covidien LLC	Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s

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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.