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.
- Company
- Nihon Kohden America Inc
- Recall Initiated
- April 29, 2024
- Posted
- June 6, 2024
- Recall Number
- Z-2025-2024
- Quantity
- 16 systems
- Firm Location
- Irvine, CA
Reason for Recall
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Distribution
U.S. Nationwide distribution in the state of IA.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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:vitalsignsTS@nihonkohden.com.