FDA Medical devices recall ·
muRata Vios Monitoring System Model 2050 recall
- Recall number
- Z-1069-2025
- Date
- (initiated April 22, 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
- 62 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Why was it recalled?
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
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
Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Distribution
Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
States: Maryland 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-1069-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.