BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000… — Class II medical device recall Z-2025-2024
Ongoing recall by Nihon Kohden America Inc, reported 2024-06-12, distributed nationwide. Due to software issue the device may give false "SpO2 Probe Failure" alarm
| Recall number | Z-2025-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Irvine, CA, United States |
| Recall initiated | 2024-04-29 |
| Classified | 2024-06-06 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 16 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04931921113691 |
| Serial numbers | 1613, 1614, 1616, 1617, 1618, 1619, 1621, 1622, 1624, 1625, 1627, 1631, 1638, 1639, 1640, 1651 |
| Model numbers | BSM-3572A |
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.
Reason for recall
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2025-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.