Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
bellavista 1000 Ventilator Recalled by Vyaire Medical Due to Vyaire Medical identified two patient safety risks during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vyaire Medical directly.
Affected Products
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Quantity: 910 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vyaire Medical
Vyaire Medical has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report