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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-1069-2025

April 22, 2024

Class II

Product summary

Firm
Murata Vios, Inc.
Event
Event 96169
Status
Ongoing
Classification
Class II
Quantity
62 units
Official record key
device-enforcement:Z-1069-2025

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 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y

Distribution pattern: Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD 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.