Recall Z-1439-2020 ยท CBK Ventilator, Continuous, Facility Use
Vyaire Medical
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 p
| Date | Nov 25, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Consignees were sent an Urgent Medical Device Recall letter beginning 11/25/2019 via overnight delivery. The letter identified affected devices, provided a description of the issue, and provided actions to be taken by distributors and end-users. A response form was asked to be returned. Questions can be directed to Vyaire's Technical Support Department at support.vent.us@vyaire.com. |
| Quantity | 116 |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163127 | bellavista 1000 Imtmedical AG, Jul 31, 2017 |