Recall Z-1169-2025— Murata Vios, Inc.
Class II · Ongoing
Class II FDA medical device recall by Murata Vios, Inc., initiated 2023-06-06. It names one FDA 510(k) clearance: K172586. Product: Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00. 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..
- Recalling firm
- Murata Vios, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-06
- Firm location
- Woodbury, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.