Monitoring Service Application — Class I medical device recall Z-0708-2025
Ongoing recall by Braemar Manufacturing, LLC, reported 2025-01-01, distributed nationwide. Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently
| Recall number | Z-0708-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Braemar Manufacturing, LLC, San Diego, CA, United States |
| Recall initiated | 2024-12-18 |
| Classified | 2024-12-23 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Reason classes | software |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0708-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.