Use cautionMedical device recall · FDA · Published May 5, 2023
Vyaire Medical Bellavista 1000e Ventilator Recall: Touchscreen Unresponsiveness Risk
Vyaire Medical recalls Bellavista 1000e ventilators with software version 6.1.0.2 or 6.1.1 due to touchscreen unresponsiveness and potential use errors that could disrupt patient care.
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.
Take action
Contact the company
📍Recalling firmVyaire Medical26125 N Riverwoods Blvd · Mettawa, IL 60045-3420
“Vyaire Medical Bellavista 1000e Ventilator Recall: Touchscreen Unresponsiveness Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58456-vyaire-medical-bellavista-1000e-ventilator-recall-touchscreen-unresponsiveness-risk. Based on FDA recall #Z-1967-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1967-2023%22&limit=1).
The FDA announced on May 5, 2023, that Vyaire Medical is voluntarily recalling the bellavista 1000e Ventilator due to potential touchscreen unresponsiveness and use errors. The agency issued recall number Z-1967-2023 for the Class II device.
How to tell if you have it
Brand: Vyaire Medical
Product: bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
UDI/DI: 07640149381115 and 07640149388879
Software Version: 6.1.0.2 and 6.1.1
Quantity: 392 units
The hazard
The ventilator's touchscreen may become unresponsive, causing the application to stop responding while ventilation continues without interruption. Additionally, operators might apply proposed settings without confirming they are suitable for the patient.
Context
GovInfoNow's records show Vyaire Medical has had 9 other recalls since July 18, 2017. Recent brand recalls include an April 10, 2025 AirLife Infant Heated Wire Circuit recall for disconnection risks and a Jan. 10, 2024 Vyaire AirLife Resuscitator recall for hypoventilation risks. Other recent recalls of similar products include the March 2, 2026 Philips Respironics Trilogy EV300 Ventilator Software Update Risk and the June 30, 2026 Getinge SERVO-U/N Ventilator Sensor Module Recall.
How to tell if you have this one
Check for the Bellavista 1000e ventilator with software version 6.1.0.2 or 6.1.1. The device has specific serial numbers and catalogue numbers listed in the recall notice.
Brand
Vyaire Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Completed
Distribution
US Nationwide Distribution
Recall number
Product, codes & lots
Quantity
Z-1966-2023
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator; UDI/DI: 10190752197664 and 07640149381115, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
910 units
Z-1967-2023
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator; UDI/DI 07640149381115 and 07640149388879, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
392 units
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your ventilator; affected units have version 6.1.0.2 or 6.1.1.
Confirm Settings Before Use
Ensure settings are confirmed suitable for the patient before applying them to avoid potential use errors.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1967-2023 (May 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1967-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.