Recall Z-0622-2022 ยท CBK Ventilator, Continuous, Facility Use
Vyaire Medical
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.
| Date | Feb 16, 2022 (initiated Dec 20, 2021) |
| Status | Terminated |
| Reason | Potential cessation in ventilation can occur under specific conditions. |
| Root cause | Software change control |
| Action | International consignees were notified of the correction via email notification beginning 12/20/2021 containing a Field Safety Notice, an Appendix to the Field Safety Notice which lists the affected units, an FSCA Distributor Response Form and an FSCA End User Response form, all in English, with the notation that localized versions were currently in translation and will be forwarded as soon as available, if applicable. The email provided information on the affected model numbers and actions to be taken by the distributor. These actions included notifying all affected end users by providing |
| Quantity | 4189 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183364 | Bellavista Imtmedical AG, Sep 13, 2019 |