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.
