Murata Vios, Inc.: Device Recall

Recall #Z-1069-2025 · 04/22/2024

Class II: Risk

Recall Details

Recall Number
Z-1069-2025
Classification
Class II
Product Type
Device
Recalling Firm
Murata Vios, Inc.
Status
Ongoing
Date Initiated
04/22/2024
Location
Woodbury, MN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
62 units

Reason for Recall

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.

Product Description

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

Distribution Pattern

Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.