FDA-Device2024-06-12Class II
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.
Nihon Kohden America Inc
Hazard
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Sold states
U.S. Nationwide distribution in the state of IA.
Affected count
16 systems
Manufactured in
15353 Barranca Pkwy, N/A, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2025-2024Don't want to check this manually?
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