Nihon Kohden America Inc Recall 94472
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.
Nihon Kohden America Inc Recall 94472 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2025-2024 |
| Event ID | 94472 |
| Event 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. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the state of IA. |
| Quantity | 16 systems |
| Recall Reason | Due to software issue the device may give false "SpO2 Probe Failure" alarm |
| Device Classification | 20240612 |
| Device 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 |
| Center Classification Date | 20240606 |
| Recall Initiation Date | 20240429 |
| Recalling Firm | Nihon Kohden America Inc |
| Initial Notification | Letter |
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