Jun

2024

FDA Recall: Device May Give False “SpO2 Probe Failure” Alarm

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.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Device May Give False “SpO2 Probe Failure” Alarm

Allison Pate

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