Braemar Manufacturing, LLC is recalling approximately 130,000 units of its Monitoring Service Application (MSA) software, versions 6.5 through 7.4. This software is used by medical facilities to process and report heart activity (ECG) data. A defect in the software caused an analysis step to be disabled, which meant that certain cardiac events recorded between July 2022 and July 2024 were not properly routed to medical staff for review. While no injuries have been reported, the loss of this data means doctors may have missed critical heart events in their patients. Healthcare providers should contact the manufacturer to arrange for a software correction.
A disabled analysis step within the software prevented certain heart rhythm events from being properly identified and reviewed by medical professionals. This failure to process and report cardiac data could lead to a delayed diagnosis or missed treatment for serious heart conditions, potentially resulting in patient harm or death.
Recall Number: Z-0708-2025. Software used to process, analyze, display, and report cardiac events in ECG data.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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