Home / Recalls / Murata Vios, Inc. / Z-0956-2025

Z-0956-2025 Class II

Recalled by Murata Vios, Inc. — Woodbury, MN

Recall Details

Product Type: Devices
Report Date: January 22, 2025
Initiation Date: June 21, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 275 units

Product Description

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

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.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.

Code Information

Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K