Recall Z-1169-2025 · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
| Date | Feb 12, 2025 (initiated Jun 6, 2023) |
| Status | Open, Classified |
| Reason | A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system. |
| Root cause | Software design |
| Action | A notification letter dated 6/6/23 was sent to customers. The purpose of this letter is to advise you of a premature failure condition that has been identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. The root cause of the underlying issue has been determined to be due to the flex circuitry degrading more rapidly than previously characterized. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system. All SpO2 pulse oximeter sensor model # L2050R have the potential for this identified e |
| Quantity | 44 systems |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172586 | Vios Monitoring System™ Model 2050 Vios Medical, Inc., Jun 22, 2018 |