CLASS II Device recall · Reported 21 Jun 2023 · FDA Enforcement Report
bellavista 1000e Ventilator recalled by Vyaire Medical
Vyaire Medical is recalling bellavista 1000e Ventilator, distributed nationwide in the US. The recall was initiated on 5 May 2023 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-1967-2023
- FDA event ID
- 92243
- Recalling firm
- Vyaire Medical, Mettawa, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 5 May 2023
- FDA classified
- 14 Jun 2023
- Reported
- 21 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 5 May 2023 | Recall initiated by company | |
| 14 Jun 2023 | Classified by FDA | +40 days |
| 21 Jun 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.
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
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.
Which lots are affected?
UDI/DI 07640149381115 and 07640149388879, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
Where was it sold?
US Nationwide Distribution
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92243| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | bellavista 1000 Ventilator recalled by Vyaire Medical | Vyaire Medical | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS I | AirLife Infant Heated Wire Circuit recalled by Vyaire Medical | Vyaire Medical | Device Malfunction | Nationwide |
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| Device | CLASS I | GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical | Vyaire Medical | Other | Nationwide |
| Device | CLASS I | AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical | Vyaire Medical | Mold | Nationwide |
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Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |