bellavista 1000e Ventilator — Class II medical device recall Z-1967-2023
Completed recall by Vyaire Medical, reported 2023-06-21, distributed nationwide. Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e:
| Recall number | Z-1967-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2023-05-05 |
| Classified | 2023-06-14 |
| Reported by FDA | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 392 units |
| UPC / GTIN / UDI-DI | 07640149381115, 07640149388879 |
| Model numbers | 301.100.130 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1967-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.