FDAApril 22, 2024device
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
murata viosmurata
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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