Class II

Medical Device Recall: 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 sig

Nihon Kohden America Inc · April 29, 2024

Reason for Recall

Due to software issue the device may give false "SpO2 Probe Failure" alarm

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.

Distribution

U.S. Nationwide distribution in the state of IA.

States Affected

NATIONWIDE

Quantity Affected

16 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2025-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Nihon Kohden America Inc Medical Device Recall: 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 sig | SafeCheck