Recall Z-0622-2022— Vyaire Medical
Class I · Terminated
Class I FDA medical device recall by Vyaire Medical, initiated 2021-12-20, terminated 2024-08-28. It names one FDA 510(k) clearance: K183364. 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..
- Recalling firm
- Vyaire Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-12-20
- Terminated
- 2024-08-28
- Firm location
- Mettawa, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Potential cessation in ventilation can occur under specific conditions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.