Device product
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Z-0708-2025
Product summary
- Event
- Event 95837
- Status
- Ongoing
- Classification
- Class I
- Quantity
- ~130,000 with 41,282 customers (1 software copy used)
- Official record key
device-enforcement:Z-0708-2025
Official wording
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.
Code information: Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
Distribution pattern: US Nationwide distribution including PR.
Derived failure modes
-
Unknown
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.