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.
Reported: June 12, 2024 Initiated: April 29, 2024 #Z-2025-2024
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
Details
- Recalling Firm
- Nihon Kohden America Inc
- Units Affected
- 16 systems
- Distribution
- U.S. Nationwide distribution in the state of IA.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nihon Kohden America Inc. Units affected: 16 systems.
Why was this product recalled? ▼
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2024. Severity: Moderate. Recall number: Z-2025-2024.
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