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U.S. Department of Health and Human Services

Class 2 Device Recall muRata Vios

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 Class 2 Device Recall muRata Viossee related information
Date Initiated by FirmApril 22, 2024
Date PostedJanuary 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1069-2025
Recall Event ID 96169
510(K)NumberK172586 
Product Classification Monitor, cardiac (incl. Cardiotachometer & rate alarm) - Product Code DRT
ProductmuRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Code Information Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Recalling Firm/
Manufacturer		 Murata Vios, Inc.
700 Commerce Dr Ste 190
Woodbury MN 55125-9239
For Additional Information ContactCustomer Service Team
866-990-1435
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionMurata 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.
Quantity in Commerce62 units
DistributionWorldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DRT
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