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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 FirmJune 21, 2021
Date PostedJanuary 16, 2025
Recall Status1 Completed
Recall NumberZ-0956-2025
Recall Event ID 96078
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 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K
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		Device Design
ActionMurata 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.
Quantity in Commerce275 units
DistributionWorldwide - US Nationwide distribution in the states of NY, LA 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.
510(K) Database510(K)s with Product Code = DRT
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