FDAFDA · Food and drugs·Recall number Z-2025-2024
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.
Published June 12, 2024 · Recall initiated: April 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to software issue the device may give false "SpO2 Probe Failure" alarm
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nihon Kohden America Inc
- Distributor
- U.S. Nationwide distribution in the state of IA.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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