# FDA recall Z-2025-2024

> **Nihon Kohden America Inc** · Class II · device recall initiated 2024-04-29.

## 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

- **Recall number:** Z-2025-2024
- **Recalling firm:** Nihon Kohden America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-29
- **Report date:** 2024-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2025-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2025-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*