Braemar Manufacturing, LLC recalls Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data rece…

Recall date

December 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0708-2025

FDA classification

Class I

Brand / firm

Braemar Manufacturing, LLC

Sold / distributed

US Nationwide distribution including PR.

Why it was recalled

Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.