Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Monitoring Service Application (MSA). Software to process Recalled by Braemar Manufacturing, LLC Due to Not all Electrocardiogram (ECG) events received July 2022-July...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Braemar Manufacturing, LLC directly.
Affected Products
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Quantity: ~130,000 with 41,282 customers (1 software copy used)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Braemar Manufacturing, LLC
Braemar Manufacturing, LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report