Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Summary
The FDA issued a Class II for Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers by Murata Vios, Inc.. Reason: A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a f.
Details
Source
Device Recall
External ID
Z-1169-2025
Action Date
2025-02-19
Status
Ongoing
Category
device
Product Description
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Lot/Code Info: All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500
Quantity Affected: 44 systems
Reason for Recall
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
Distribution
US Nationwide distribution in the state of NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-06
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 142 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-1169-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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