CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report

BSM-3000 Series Bedside Monitor recalled by Nihon Kohden America

Nihon Kohden America is recalling BSM-3000 Series Bedside Monitor, distributed nationwide in the US. The recall was initiated on 29 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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

Quantity recalled16 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2025-2024
FDA event ID: 94472
Recalling firm: Nihon Kohden America, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Apr 2024
FDA classified: 6 Jun 2024
Reported: 12 Jun 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

29 Apr 2024	Recall initiated by company
6 Jun 2024	Classified by FDA	+38 days
12 Jun 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

U.S. Nationwide distribution in the state of IA.

Nationwide Iowa

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

U.S. Nationwide distribution in the state of IA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nihon Kohden America

All 10

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	Adult Cap-ONE Biteblock recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide
6 Nov 2024Device	CLASS II	Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m recalled	Nihon Kohden America	Device Malfunction	29 states
6 Nov 2024Device	CLASS II	Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter recalled	Nihon Kohden America	Device Malfunction	29 states
10 Mar 2021Device	CLASS II	WMTS Telemetry Receiver, Multiple Patient Receiver recalled	Nihon Kohden America	Other	46 states
3 Feb 2021Device	CLASS II	PSG-1100 Sleep Diagnostic System recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide