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Recall Observatory FDA recall evidence

Device 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.

Z-2025-2024

April 29, 2024

Class II

Product summary

Firm
Nihon Kohden America Inc
Event
Event 94472
Status
Ongoing
Classification
Class II
Quantity
16 systems
Official record key
device-enforcement:Z-2025-2024

Official wording

Reason: Due to software issue the device may give false "SpO2 Probe Failure" alarm

Code information: Model/Catalog Number: BSM-3572A UDI-DI code: 04931921113691 Serial Numbers: 1613, 1614, 1616, 1617, 1618, 1619, 1621, 1622, 1624, 1625, 1627, 1631, 1638, 1639, 1640, 1651

Distribution pattern: U.S. Nationwide distribution in the state of IA.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue the device may give false "SpO2 Probe Failure