Z-0956-2025Class II

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

Name: Z-0956-2025 muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Creator: Murata Vios, Inc.
Published: 2021-06-21
License: https://open.fda.gov/license/

Murata Vios, Inc. / initiated 2021-06-21 / Completed / root cause: design

FDA source

Murata Vios, Inc. began a recall of muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate on 2021-06-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0956-2025
Classification: Class II
Status: Completed
Initiated: 2021-06-21
Posted: 2025-01-16
Recalling firm: Murata Vios, Inc.
Product: muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Product code: DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Reason for recall: 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 tag: design
FDA 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 in commerce: 275 units
Distribution: Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.
Product codes and lots: Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0956-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0956-2025	Class II	Completed	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code DRT

K172586Class IIVios Monitoring System™ Model 2050Vios Medical, Inc. / cleared 2018-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)