Reported Jun 12, 2024 · Ongoing

BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to…

Nihon Kohden America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nihon Kohden America Inc · 15353 Barranca Pkwy · Irvine, CA · 92618-2216

Is this the product you have?

  • 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.
Lot codes and dates
  • Model/Catalog NumberBSM-3572A
  • UDI-DI code04931921113691
  • Serial Numbers
    • 1613
    • 1614
    • 1616
    • 1617
    • 1618
    • 1619
    • 1621
    • 1622
    • 1624
    • 1625
    • 1627
    • 1631
    • 1638
    • 1639
    • 1640
    • 1651
Amount recalled
16 systems

Where it was sold

  • Nationwide
  • IA

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.