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.
FDA Recall Z-1439-2020 · Posted None
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Recalling FirmVyaire Medical
Recall StatusTerminated
Product CodeCBK
Date Initiated2019-11-25
Date Terminated2023-08-08
Product Quantity116
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.
Firm 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 [email protected].
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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