Device recall

Z-2025-2024: BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series…

FDA device recall · Class II · Nihon Kohden America Inc

Key facts

Recall number (Z-number) Z-2025-2024
Recall event 94472
Product 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 code MHX
Recalling firm Nihon Kohden America Inc
Recall class Class II
Status Open, Classified
FEI number 2080783

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)