Z-2025-2024Class II

BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is...

Name: Z-2025-2024 BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is...
Creator: Nihon Kohden America Inc
Published: 2024-04-29
License: https://open.fda.gov/license/

Nihon Kohden America Inc / initiated 2024-04-29 / Open, Classified / root cause: software

FDA source

Nihon Kohden America Inc began a recall of 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... on 2024-04-29. FDA classified it as Class II and gives the reason as "Due to software issue the device may give false "SpO2 Probe Failure" alarm". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2025-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-29
Posted: 2024-06-06
Recalling firm: Nihon Kohden America Inc
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 Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Due to software issue the device may give false "SpO2 Probe Failure" alarm
Root cause tag: software
FDA root cause: Software design
Action: On 4/29-30/2024, the firm sent "URGENT: MEDICAL DEVICE CORRECTION" Letters via FedEx to customer informing them that due to a software issue, the SpO2 probe failure message may occur when the value of the resistor built into the SpO2 relay code is incorrectly determined to be outside the normal range. This issue applies to all Life Scope BSM-3572A bedside monitors with software version 08-94. Customer are instructed to: 1. Please notify all individuals that need to be made aware of this issue/correction, and that this Notification should be posted with or near the affected products. Please notify any facilities if any affected product has been transferred to another facility. 2. Complete the attached form and return to Nihon Kohden. 3. If the SpO2 probe failure message is received and the probe appears undamaged, the bedside monitor may be providing an incorrect alarm. This issue may be temporarily resolved by turning off and restarting the BSM-3572A. 4. If adverse reactions or quality problems are experienced with the use of this product, please report to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. 5. If adverse reactions or quality problems are experienced with the use of this product, or if there are any questions or need for further assistance, please contact Nihon Kohden Technical Support at: 1-800-325-0283 or email mailto:[email protected].
Quantity in commerce: 16 systems
Distribution: U.S. Nationwide distribution in the state of IA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2025-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2025-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-06

Product code MHX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)