bellavista 1000 ventilator — Class II medical device recall Z-1439-2020
Terminated recall by Vyaire Medical, reported 2020-03-11, distributed nationwide. The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority ala
| Recall number | Z-1439-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2019-11-25 |
| Classified | 2020-03-04 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2023-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 116 |
| Serial numbers | MB170104, MB170118, MB170151, MB170202, MB230000, MB230020, MB230024, MB230027, MB230031, MB230033, MB230035, MB230036, MB230037, MB230038, MB230039, MB230040, MB230041, MB230046, MB230048, MB230049, MB230052, MB230053, MB230054, MB230055, MB230056 and 91 more |
| Model numbers | 301.100.030 |
Product
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor controlled inspiratory valve.
Reason for recall
The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.
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-1439-2020. 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.