FDA Medical devices recall ·
Vios Monitoring System Bedside Monitor Model BSM2050 recall
- Recall number
- Z-1292-2025
- Date
- (initiated August 9, 2024)
- 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
- 50
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Vios Monitoring System Bedside Monitor Model BSM2050
Why was it recalled?
Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
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
1.56.01 UDI: +B595BSM20500/$$7V1.56.01/16D20230630S 1.57.20 UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y Software Versions 1.56.01 and 1.57.20
Distribution
US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.
States: Florida Louisiana Maryland Montana New York Ohio Texas
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-1292-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.