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bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controll...

FDA Device Recall #Z-1439-2020 — Class II — November 25, 2019

Recall Summary

Recall Number Z-1439-2020
Classification Class II — Moderate risk
Date Initiated November 25, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Vyaire Medical
Location Mettawa, IL
Product Type Devices
Quantity 116

Product Description

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 Pattern

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

Lot / Code Information

Serial numbers: MB170104, MB170118, MB170151, MB170202, MB230000, MB230020, MB230024, MB230027, MB230031, MB230033, MB230035, MB230036, MB230037, MB230038, MB230039, MB230040, MB230041, MB230046, MB230048, MB230049, MB230052, MB230053, MB230054, MB230055, MB230056, MB230057, MB230058, MB230059, MB230060, MB230061, MB230062, MB230063, MB230064, MB230065, MB230066, MB230067, MB230068, MB230069, MB230070, MB230071, MB230072, MB230073, MB230074, MB230075, MB230076, MB230077, MB230078, MB230079, MB230080, MB230081, MB230082, MB230083, MB230084, MB230085, MB230086, MB230087, MB230088, MB230089, MB230090, MB230091, MB230092, MB230093, MB230094, MB230095, MB230097, MB230098, MB230099, MB230100, MB230101, MB230102, MB230104, MB230190, MB230191, MB230194, MB230195, MB230196, MB230197, MB230201, MB230204, MB230205, MB230207, MB230209, MB230210, MB230217, MB230219, MB230220, MB230221, MB230222, MB230227, MB230228, MB230229, MB230230, MB230231, MB230232, MB230233, MB230243, MB230244, MB230246, MB230247, MB230249, MB230251, MB230253, MB230256, MB230258, MB230260, MB230261, MB230262, MB230263, MB230266, MB230270, MB230274, MB230275, MB230277, MB230294, MB230297, MB230298.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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