Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
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.
US Nationwide distribution including PR.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0708-2025