Z-1169-2025 Class II Ongoing
FDA device recall Z-1169-2025 was initiated by Murata Vios, Inc. on June 6, 2023 and is designated Class II. 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 con… The recall status is ongoing. Affected quantity: 44 systems.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- June 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 systems
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.
Distribution Pattern
US Nationwide distribution in the state of NY.
Code Information
All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500