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Recall Observatory FDA recall evidence

Device product

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

Z-0956-2025

June 21, 2021

Class II

Product summary

Firm
Murata Vios, Inc.
Event
Event 96078
Status
Completed
Classification
Class II
Quantity
275 units
Official record key
device-enforcement:Z-0956-2025

Official wording

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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.