FDA recall Z-2025-2024

Nihon Kohden America Inc · Class II · device

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 for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-04-29
Report date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2025-2024