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Completed

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

FDA Recall Z-0956-2025 · Posted 2025-01-16

Recalling FirmMurata Vios, Inc.
Recall StatusCompleted
Product CodeDRT
Date Initiated2021-06-21
Product Quantity275 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 Vios notified their consignees via email on 06/21/2021. The notice explained the issue and provided workflow guidance to prevent the problem from occurring while a software update was being created. The firm followed up with another email on 08/24/2021 informing the consignees that the software update was ready for deployment and to request scheduling an appointment for the upgrade.

Root Cause

Device Design

Distribution Pattern

Worldwide - US Nationwide distribution in the states of NY, LA 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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