muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Summary
The FDA issued a Class II for muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including car by Murata Vios, Inc.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-1069-2025
Action Date
2025-02-05
Status
Ongoing
Category
device
Product Description
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Lot/Code Info: Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Quantity Affected: 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.
Distribution
Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-22
Company
Woodbury, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Murata Vios, Inc. has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Murata Vios, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Murata Vios, Inc. have FDA actions?
Murata Vios, Inc. has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1069-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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