Reported Jan 22, 2025 · Completed
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Murata Vios, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Murata Vios, Inc. · 700 Commerce Dr Ste 190 · Woodbury, MN · 55125-9239
Is this the product you have?
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Lot codes and dates
- Soft ware version 1.49.02
- UDI+B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00
- UDI+B595BSM20500/\$\$7V1.52.00/16D20210305K
- Amount recalled
- 275 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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