Dec

2024

FDA Recall: ECG Events Not Reviewed – Disabled in Monitoring Software

Company: Braemar Manufacturing, LLC
Date of Enforcement Report: 12/23/2024
Class I

PRODUCT

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

Recall Number:

Z-0708-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Braemar Manufacturing, LLC

VOLUME OF PRODUCT IN COMMERCE:

~130,000 with 41,282 customers (1 software copy used)

DISTRIBUTION:

US Nationwide distribution including PR.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: ECG Events Not Reviewed – Disabled in Monitoring Software

Allison Pate

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