Recall Z-2025-2024— Nihon Kohden America Inc
Class II · Ongoing
Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2024-04-29. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to software issue the device may give false "SpO2 Probe Failure" alarm.
- Recalling firm
- Nihon Kohden America Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-29
- Firm location
- Irvine, CA, United States
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.
Reason for recall
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Data sourced from openFDA. This site is unofficial and independent of the FDA.