FDA Medical Device Recalls (openFDA)
Murata Vios, Inc.: muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Recall number
- Z-1069-2025
- Recalling firm
- Murata Vios, Inc.
- Product
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Status
- Open, Classified
- Initiated
- 2024-04-22
- Posted
- 2025-01-30
- Terminated
- not on file
- 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 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.
- Root cause
- Software design
- Action
- Murata sent an email to its consignees on 04/22/2024 to inform them of the issue and provide the correct workflow to address the issue. The email further requested the posting of the workflow guidance in nurse training areas, add to in-services, and other recurrent training for Vios Monitoring. If the flickering issue is observed on the central station monitor, immediately begin using the bedside tablet for all patient monitoring and alarm management and contact Vios Support at 866-990-1434.
- Quantity
- 62 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
- Lot, serial or model codes
- Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
- 510(k) numbers
- ["K172586"]
- PMA numbers
- not on file
- Product code
- DRT
- Firm FEI
- 3015328411
- Firm city
- Woodbury
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28