Recall Z-0708-2025— Braemar Manufacturing, LLC
Class I · Ongoing
Class I FDA medical device recall by Braemar Manufacturing, LLC, initiated 2024-12-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.. Reason: 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..
- Recalling firm
- Braemar Manufacturing, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-12-18
- Firm location
- San Diego, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.