FDA Device recall Z-1967-2023
bellavista 1000e Ventilator, Catalogue Number 301.100.130
- FDA Device
- Class II
- completed
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of bellavista 1000e Ventilator, Catalogue Number 301.100.130 by Vyaire Medical, citing 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 unres….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1967-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-05-05 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Vyaire Medical |
| Distribution | US |
Product
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Reason
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.
Identifiers
| code_info | UDI/DI 07640149381115 and 07640149388879, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1967-2023%22
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