muRata Vios Monitoring System recall
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Why was muRata Vios Monitoring System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
- Product
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Recalling firm
- Murata Vios, Inc.
- Quantity
- 62 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
- Recall date
- February 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)