Z-2025-2024 Class II Ongoing
FDA device recall Z-2025-2024 was initiated by Nihon Kohden America Inc on April 29, 2024 and is designated Class II. Reason for recall: Due to software issue the device may give false "SpO2 Probe Failure" alarm The recall status is ongoing. Affected quantity: 16 systems.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2024
- Initiation Date
- April 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 systems
Product 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 for Recall
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Distribution Pattern
U.S. Nationwide distribution in the state of IA.
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