FDAApril 29, 2024device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

nihon kohden americanihonnihon kohden

UPCs

04931921113691

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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