FDA-Device2025-01-01Class I
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Braemar Manufacturing, LLC
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.
Sold states
US Nationwide distribution including PR.
Affected count
~130,000 with 41,282 customers (1 software copy used)
Manufactured in
3890 Murphy Canyon Rd Ste 100, San Diego, CA, United States
Products
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0708-2025Don't want to check this manually?
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