FDA Device recall Z-0708-2025
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible…
- FDA Device
- Class I
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class I recall of Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible… by Braemar Manufacturing, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0708-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-18 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Braemar Manufacturing |
| Distribution | US |
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.
Identifiers
| code_info | Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0708-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.