Drug recall
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
FDA recall event 92243 · Class II · Vyaire Medical
Key facts
| Event ID | 92243 |
|---|---|
| Recall numbers | Z-1966-2023, Z-1967-2023 |
| Recalling firm | Vyaire Medical |
| Product type | Devices |
| Products | bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator, bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 5, 2023 |
| Report date | Jun 21, 2023 |
| City | Mettawa |
| State | IL |
| Country | United States |
| FEI number | 3013421741 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: