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

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution including PR. Quantity: ~130,000 with 41,282 customers (1 software copy used) Lot/code info: Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.