CLASS II Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Monitoring System recalled by Murata Vios
Murata Vios is recalling muRata Vios Monitoring System, distributed nationwide in the US. The recall was initiated on 21 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0956-2025
- FDA event ID
- 96078
- Recalling firm
- Murata Vios, Woodbury, MN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 21 Jun 2021
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 21 Jun 2021 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +1305 days |
| 22 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Where it was distributed
Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.
Questions about this recall
Is Monitoring System recalled?
Yes. Murata Vios recalled Monitoring System on 21 Jun 2021. The recall is Class II and its status is Completed. Recall number Z-0956-2025.
Why was it 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.
Which lots are affected?
Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K
Where was it sold?
Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Murata Vios
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vios Monitoring System Bedside Monitor recalled by Murata Vios | Murata Vios | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Vios Monitoring System Bedside Monitor recalled by Murata Vios | Murata Vios | Device Malfunction | Nationwide |
| Device | CLASS II | Monitoring System recalled by Murata Vios | Murata Vios | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |