Vyaire Medical: Medical Device Recall in 2023 - (Recall #: Z-1967-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

Product Classification:

Class II

Date Initiated: May 5, 2023

Date Posted: June 21, 2023

Recall Number: Z-1967-2023

Event ID: 92243

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.

Status: Completed

Product Quantity: 392 units

Code Information:

UDI/DI 07640149381115 and 07640149388879, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated