Vyaire Medical recalls Bellavista 1000 ventilators with catalog number 301.100.030 due to intermittent failures including lack of high-priority alarms and non-responsive touch screens. Affected units have specific serial numbers listed in the 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.
Vyaire Medical is recalling Bellavista 1000 ventilators with catalog number 301.100.030 because they may experience intermittent failures like missing high-priority alarms or unresponsive touch screens. This could lead to unsafe patient ventilation if the ventilator fails to alert healthcare providers during critical situations.
The ventilator may stop producing high-priority alarms or become unresponsive to touch, meaning healthcare providers might not be alerted to critical issues like airway obstructions or equipment failures. This could lead to unsafe patient ventilation if the ventilator fails to alert staff during emergencies.
Healthcare providers using the Bellavista 1000 ventilator for patient care are most at risk. Patients receiving ventilation support through this device could be affected if the ventilator malfunctions.
Check for the catalog number 301.100.030 on the ventilator. Affected units have specific serial numbers listed in the recall, including MB170104 through MB230298.
Review the serial numbers listed in the recall to determine if your ventilator is affected.
The Bellavista 1000 ventilators may experience intermittent failures, including lack of high-priority alarms or unresponsive touch screens, which could lead to unsafe patient ventilation.
Check the serial number against the list of affected units provided in the recall. If it matches, contact Vyaire Medical for further instructions.
Yes, the ventilator may not alert healthcare providers to critical issues like airway obstructions or equipment failures, which could lead to unsafe patient ventilation.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1439-2020 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1439-2020 from Vyaire Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.