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
1613161416161617161816191621162216241625162716311638163916401651
- 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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