Braemar Manufacturing, LLC: Device Recall
Recall #Z-0708-2025 · 12/18/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-0708-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Braemar Manufacturing, LLC
- Status
- Ongoing
- Date Initiated
- 12/18/2024
- Location
- San Diego, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- ~130,000 with 41,282 customers (1 software copy used)
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.
Product Description
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Distribution Pattern
US Nationwide distribution including PR.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.