Class I

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

Braemar Manufacturing, LLC · December 18, 2024

Reason for Recall

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.

Distribution

US Nationwide distribution including PR.

States Affected

NATIONWIDE

Quantity Affected

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

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0708-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Braemar Manufacturing, LLC Medical Device Recall: Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. | SafeCheck