medical Class I Updated 2025-01-01

Braemar Manufacturing, LLC recalls Monitoring Service Application (MSA). Software to process, a

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
View official government recall

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