# FDA recall Z-1439-2020

> **Vyaire Medical** · Class II · device recall initiated 2019-11-25.

## 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.

## Distribution

US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.

## Key facts

- **Recall number:** Z-1439-2020
- **Recalling firm:** Vyaire Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-25
- **Report date:** 2020-03-11
- **Termination date:** 2023-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mettawa, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1439-2020

## Citation

> AI Analytics. FDA recall Z-1439-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1439-2020. Source: US FDA. Licensed CC0.

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