# FDA recall Z-1967-2023

> **Vyaire Medical** · Class II · device recall initiated 2023-05-05.

## Product

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

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1967-2023
- **Recalling firm:** Vyaire Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-05-05
- **Report date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mettawa, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1967-2023

## Citation

> AI Analytics. FDA recall Z-1967-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1967-2023. Source: US FDA. Licensed CC0.

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