FDA Device recall Z-2025-2024
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and…
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and… by Nihon Kohden America, citing due to software issue the device may give false "SpO2 Probe Failure" alarm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2025-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-29 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nihon Kohden America |
| Distribution | US |
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
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Identifiers
| code_info | Model/Catalog Number: BSM-3572A UDI-DI code: 04931921113691 Serial Numbers: 1613, 1614, 1616, 1617, 1618, 1619, 1621, 1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Nihon Kohden America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2025-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.