Nihon Kohden America Inc: Device Recall

Recall #Z-2025-2024 · 04/29/2024

Class II: Risk

Recall Details

Recall Number: Z-2025-2024
Classification: Class II
Product Type: Device
Recalling Firm: Nihon Kohden America Inc
Status: Ongoing
Date Initiated: 04/29/2024
Location: Irvine, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16 systems

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 Pattern

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

Other Recalls by Nihon Kohden America Inc

Class II: Risk 09/18/2024

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Class II: Risk 09/18/2024

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

View all recalls by Nihon Kohden America Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.