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Open, Classified

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

FDA Recall Z-1069-2025 · Posted 2025-01-30

Recalling FirmMurata Vios, Inc.
Recall StatusOpen, Classified
Product CodeDRT
Date Initiated2024-04-22
Product Quantity62 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.

Firm Action

Murata sent an email to its consignees on 04/22/2024 to inform them of the issue and provide the correct workflow to address the issue. The email further requested the posting of the workflow guidance in nurse training areas, add to in-services, and other recurrent training for Vios Monitoring. If the flickering issue is observed on the central station monitor, immediately begin using the bedside tablet for all patient monitoring and alarm management and contact Vios Support at 866-990-1434.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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