Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Reported: January 1, 2025 Initiated: December 18, 2024 #Z-0708-2025
Product Description
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
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.
Details
- Recalling Firm
- Braemar Manufacturing, LLC
- Units Affected
- ~130,000 with 41,282 customers (1 software copy used)
- Distribution
- US Nationwide distribution including PR.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.. Recalled by Braemar Manufacturing, LLC. Units affected: ~130,000 with 41,282 customers (1 software copy used).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Critical. Recall number: Z-0708-2025.
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