Reported Jan 1, 2025 · Ongoing
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data…
Braemar Manufacturing, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Braemar Manufacturing, LLC · 3890 Murphy Canyon Rd Ste 100 · San Diego, CA · 92123-4448
Is this the product you have?
- Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
- Lot codes and dates
- Product CodeN/A
- UDI codeN/A Software Version - 6.5 to 7.4
- Amount recalled
- ~130,000 with 41,282 customers (1 software copy used)
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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