FDA Medical devices recall ·
Vios Monitoring System Bedside Monitor, Model BSM2050… recall
- Recall number
- Z-1169-2025
- Date
- (initiated June 6, 2023)
- Company / brand
- Murata Vios, Inc.
700 Commerce Dr Ste 190, Woodbury, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 44 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500
Distribution
US Nationwide distribution in the state of NY.
States: New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1169-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.