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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Nihon Kohden America Inc: BSM-3000 Series Bedside Monitor Recalled for False SpO2 Alarms

Agency Publication Date: June 6, 2024
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Summary

Nihon Kohden America Inc has recalled 16 units of the Life Scope BSM-3000 Series Bedside Monitor, specifically model BSM-3572A. A software defect causes the device to trigger a false "SpO2 Probe Failure" alarm, which incorrectly indicates that the blood oxygen monitoring sensor has failed. These monitors are used in medical facilities to track vital signs, and the affected units were distributed in Iowa. Consumers should contact the manufacturer or their healthcare provider for specific instructions regarding this software issue.

Risk

The software issue causes false alarms that can distract medical staff or lead them to believe that critical blood oxygen monitoring is unavailable, potentially delaying patient care or causing unnecessary troubleshooting during medical procedures.

What You Should Do

  1. Check your device's model and catalog number to see if it is a BSM-3000 Series Bedside Monitor, Model BSM-3572A.
  2. Locate the serial number on your device and verify if it matches one of the 16 affected units: 1613, 1614, 1616, 1617, 1618, 1619, 1621, 1622, 1624, 1625, 1627, 1631, 1638, 1639, 1640, or 1651.
  3. If you identify an affected monitor, contact Nihon Kohden America Inc at their Irvine, California location or your facility's medical equipment manager for information on software corrections.
  4. Contact your healthcare provider or the manufacturer for further instructions regarding the continued use of these monitors or potential repair/refund options.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BSM-3000 Series Bedside Monitor REF BSM-3572A
Model / REF:
BSM-3572A
UDI-DI 04931921113691
Lot Numbers:
Serial Numbers: 1613
Serial Numbers: 1614
Serial Numbers: 1616
Serial Numbers: 1617
Serial Numbers: 1618
Serial Numbers: 1619
Serial Numbers: 1621
Serial Numbers: 1622
Serial Numbers: 1624
Serial Numbers: 1625
Serial Numbers: 1627
Serial Numbers: 1631
Serial Numbers: 1638
Serial Numbers: 1639
Serial Numbers: 1640
Serial Numbers: 1651

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94472
Status: Active
Manufacturer: Nihon Kohden America Inc
Sold By: Medical facilities
Manufactured In: United States
Units Affected: 16 systems
Distributed To: Iowa

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.