Vyaire Medical recalls Bellavista 1000 and 1000e ventilators with specific serial numbers due to potential breathing support failure. Affected units may need repair or replacement.
Potential cessation in ventilation can occur under specific conditions.
Vyaire Medical is recalling Bellavista 1000 and 1000e ventilators with certain serial numbers because they could stop providing breathing support under specific conditions. This is serious for patients who rely on these ventilators for life support.
The ventilators could stop delivering breathing support if specific conditions are met, such as improper setup or software issues. This might lead to patients not getting enough oxygen and could cause breathing difficulties.
Patients using these ventilators for breathing support, particularly those in hospitals or home care settings. Healthcare providers and families managing ventilator care are most at risk.
Check for the model name 'Bellavista 1000' or 'Bellavista 1000e' with serial numbers starting with 07640149381115 or 07640149388879. These units were sold with hardware generation G6 and software version V6.0.1600.0 or higher.
Look for serial numbers starting with 07640149381115 (Bellavista 1000) or 07640149388879 (Bellavista 1000e).
Reach out to Vyaire Medical for guidance on next steps if you have the recalled ventilators.
No, but you should check if your ventilator is affected and contact Vyaire Medical for specific instructions.
Check the serial number; if it starts with 07640149381115, it is affected and you should contact Vyaire Medical.
Yes, the ventilators could stop providing breathing support under specific conditions, which might lead to breathing difficulties.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0622-2022 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-0622-2022 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.
