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-0956-2025
- Recalling firm
- Murata Vios, Inc.
- Product
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Status
- Completed
- Initiated
- 2021-06-21
- Posted
- 2025-01-16
- 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
- Device Design
- Action
- Murata Vios notified their consignees via email on 06/21/2021. The notice explained the issue and provided workflow guidance to prevent the problem from occurring while a software update was being created. The firm followed up with another email on 08/24/2021 informing the consignees that the software update was ready for deployment and to request scheduling an appointment for the upgrade.
- Quantity
- 275 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.
- Lot, serial or model codes
- Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K
- 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