Summary
The FDA issued a Class II for Vios Monitoring System Bedside Monitor Model BSM2050 by Murata Vios, Inc.. Reason: Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet .
Details
Source
Device Recall
External ID
Z-1292-2025
Action Date
2025-03-12
Status
Ongoing
Category
device
Product Description
Vios Monitoring System Bedside Monitor Model BSM2050
Lot/Code Info: 1.56.01 UDI: +B595BSM20500/$$7V1.56.01/16D20230630S 1.57.20 UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y Software Versions 1.56.01 and 1.57.20
Quantity Affected: 50
Reason for Recall
Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
Distribution
US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-09
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 132 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-1292-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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