FDA recall Z-1069-2025

Murata Vios, Inc. · Class II · device

Product

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

Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.

Key facts

Status
Ongoing
Initiation date
2024-04-22
Report date
2025-02-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woodbury, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2025