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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94472

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 29, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Nihon Kohden America Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2025-2024
Recall number
Z-2025-2024
Initiated
April 29, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Nihon Kohden America Inc
Quantity
16 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue the device may give false "SpO2 Probe Failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.