FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2025-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-2025-2024
- Event ID
- 94472
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Nihon Kohden America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2024
- Initiation Date
- April 29, 2024
- Classification Date
- June 6, 2024
- Address
- 15353 Barranca Pkwy, N/A, Irvine, CA, 92618-2216, United States
Description
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.
Reason
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Code Info
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
U.S. Nationwide distribution in the state of IA.
Quantity
16 systems