Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 record physiological data to provide cardiac and vital signs monitoring within a medical facility.

U.S. FDA — Device Enforcement · United States · 2024-04-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2025-2024
Date of alert
2024-04-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nihon Kohden America Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04931921113691
Reported risk: Due to software issue the device may give false "SpO2 Probe Failure" alarm
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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