Recall Z-2025-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Nihon Kohden America Inc
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.
| Date | Jun 6, 2024 (initiated Apr 29, 2024) |
| Status | Open, Classified |
| Reason | Due to software issue the device may give false "SpO2 Probe Failure" alarm |
| 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 |
| Quantity | 16 systems |
| Distribution | U.S. Nationwide distribution in the state of IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.