Z-0708-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2025
- Initiation Date
- December 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- ~130,000 with 41,282 customers (1 software copy used)
Product Description
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.
Distribution Pattern
US Nationwide distribution including PR.
Code Information
Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4