FDA Device recall Z-0622-2022
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130
- FDA Device
- Class I
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class I recall of bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130 by Vyaire Medical, citing potential cessation in ventilation can occur under specific conditions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0622-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-12-20 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Vyaire Medical |
| Distribution | US |
Product
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
Reason
Potential cessation in ventilation can occur under specific conditions.
Identifiers
| code_info | Hardware generation G6, software version V6.0.1600.0 or higher installed, all serial numbers. UDI 07640149381115 (bell…Hardware generation G6, software version V6.0.1600.0 or higher installed, all serial numbers. UDI 07640149381115 (bellavista 1000 ventilator) and 07640149388879 (bellavista 1000e ventilator). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0622-2022%22
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