Home / Recalls / Medical Devices
Braemar Manufacturing, LLC recalls Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data recei
Recalled January 1, 2025 · FDA recall Z-0708-2025 · Braemar Manufacturing
Hazard
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. · FDA Class I
Units
~130,000 with 41,282 customers (1 software copy used)
Sold at
US Nationwide distribution including PR.
Description
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.
Product
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Manufacturer(s)
Braemar Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →