Device product
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility.
Z-2025-2024
Product summary
- Event
- Event 94472
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 systems
- Official record key
device-enforcement:Z-2025-2024
Official wording
Reason: Due to software issue the device may give false "SpO2 Probe Failure" alarm
Code information: Model/Catalog Number: BSM-3572A UDI-DI code: 04931921113691 Serial Numbers: 1613, 1614, 1616, 1617, 1618, 1619, 1621, 1622, 1624, 1625, 1627, 1631, 1638, 1639, 1640, 1651
Distribution pattern: U.S. Nationwide distribution in the state of IA.
Derived failure modes
-
Device software or design
software issue the device may give false "SpO2 Probe Failure