Nihon Kohden America Inc: Medical Device Recall in 2024 - (Recall #: Z-2025-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 29, 2024

Date Posted: June 12, 2024

Recall Number: Z-2025-2024

Event ID: 94472

Reason for Recall:

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

Status: Ongoing

Product Quantity: 16 systems

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.

Voluntary or Mandated:

Voluntary: Firm initiated