Drug recall
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG…
FDA recall event 95837 · Class I · Braemar Manufacturing, LLC
Key facts
| Event ID | 95837 |
|---|---|
| Recall numbers | Z-0708-2025 |
| Recalling firm | Braemar Manufacturing, LLC |
| Product type | Devices |
| Products | Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 18, 2024 |
| Report date | Jan 1, 2025 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3003584029 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: