Murata Vios recalls Model 2050 bedside cardiac monitors with software versions 1.49.02 and 1.52.00. Distorted ECG waveforms and flickering vital signs may occur during setup, potentially causing inaccurate readings.
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.
Murata Vios is recalling its Model 2050 bedside cardiac monitors that have software versions 1.49.02 and 1.52.00. These monitors can distort and flicker ECG waveforms during setup, which might lead to inaccurate patient vital signs.
The issue occurs only when setting up the monitor for the first time, causing ECG waveforms and vital signs to flicker or flash rapidly. This distortion happens exclusively on the Central Station Monitor in the patient tiles view and does not affect other monitoring points.
Healthcare professionals using the Model 2050 bedside cardiac monitors with specific software versions are affected. Patients using these monitors may experience inaccurate vital signs during setup.
Check for the model number '2050' on the monitor. The software versions 1.49.02 (UDI: +B595BSM20500/$$7V1.49.02/16D20200504S) and 1.52.00 (UDI: +B595BSM20500/$$7V1.52.00/16D20210305K) are affected.
Verify the software version on the monitor by checking the UDI label for versions 1.49.02 or 1.52.00.
The monitor can distort and flicker ECG waveforms and vital signs during setup, which may lead to inaccurate readings.
No, the issue only occurs during setup and does not affect normal monitoring after setup. The recall does not require immediate discontinuation.
Check the UDI label for software versions 1.49.02 (UDI: +B595BSM20500/$$7V1.49.02/16D20200504S) or 1.52.00 (UDI: +B595BSM20500/$$7V1.52.00/16D20210305K).
We’ve drafted a message you can send Murata Vios to request your refund or repair — edit it as you like.
Subject: Recall Z-0956-2025 — Murata Vios Murata Vios Hello, I own a Murata Vios that is covered by recall Z-0956-2025 from Murata Vios. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.