Bedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms
Nihon Kohden's BSM-3000 Series Bedside Monitors may produce false SpO2 probe failure alarms due to a software issue. Healthcare facilities should contact the manufacturer for guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall without reported illnesses or injuries. However, false alarms on a life-critical cardiac and vital signs monitoring device represent a risk-of-harm condition, as false alerts could mask real physiological emergencies.
Plain-English summary
The BSM-3000 Series Bedside Monitoring System, manufactured by Nihon Kohden America Inc, is intended to monitor and display cardiac and vital signs within medical facilities. Due to a software issue, the device may generate false "SpO2 Probe Failure" alarms.
This recall affects 16 units with serial numbers 1613, 1614, 1616, 1617, 1618, 1619, 1621, 1622, 1624, 1625, 1627, 1631, 1638, 1639, 1640, and 1651. These units were distributed in Iowa.
Healthcare facilities using affected units should contact Nihon Kohden America Inc for instructions on how to address this software issue.
The recalled product
- 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.
- Manufacturer
- Nihon Kohden America Inc
- Hazard
- false-alarm
- software-defect
- monitoring-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
Distributed nationwide across the United States.
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