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U.S. Department of Health and Human Services

Class 2 Device Recall Vios

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 Class 2 Device Recall Viossee related information
Date Initiated by FirmAugust 09, 2024
Date PostedMarch 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1292-2025
Recall Event ID 96252
510(K)NumberK172586 
Product Classification Monitor, cardiac (incl. Cardiotachometer & rate alarm) - Product Code DRT
ProductVios Monitoring System Bedside Monitor Model BSM2050
Code Information 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
Recalling Firm/
Manufacturer		 Murata Vios, Inc.
700 Commerce Dr Ste 190
Woodbury MN 55125-9239
For Additional Information ContactCustomer Service Team
651-764-8467
Manufacturer 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.
FDA Determined
Cause 2		Labeling design
ActionThe firm sent a single page of instructions to customers on August 9, 2024 via email. Customers were informed that tablets should remain plugged into a wall outlet when the tablet is not in use. The tablet battery should not be allowed to fully deplete at any time during patient monitoring or when not in use.
Quantity in Commerce50
DistributionUS Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.
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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