Company: Nihon Kohden America Inc
Date of Enforcement Report: 6/6/2024
Class II
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
Recall Number:
Z-2025-2024
REASON:
Due to software issue the device may give false “SpO2 Probe Failure” alarm.
RECALLING FIRM/MANUFACTURER:
Nihon Kohden America Inc
VOLUME OF PRODUCT IN COMMERCE:
16 systems
DISTRIBUTION:
U.S. Nationwide distribution in the state of IA.
