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Is the Evita Infinity V500 Ventilator; Babylog Infinity VN500… safe?

Draeger Medical, Inc. · Recalled Feb 04, 2016
No — the Evita Infinity V500 Ventilator; Babylog Infinity VN500… was recalled on Feb 04, 2016 due to a safety issue. Recalled for a safety or quality concern — see details. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
Recalled for a safety or quality concern — see details.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.

Evita Infinity V500 Ventilator; Babylog Infinity VN500…: common questions

Is the Evita Infinity V500 Ventilator; Babylog Infinity VN500… safe?
No. The Evita Infinity V500 Ventilator; Babylog Infinity VN500… was recalled on Feb 04, 2016 due to a safety issue. Recalled for a safety or quality concern — see details.
Has the Evita Infinity V500 Ventilator; Babylog Infinity VN500… been recalled?
Yes. The Evita Infinity V500 Ventilator; Babylog Infinity VN500… was recalled on Feb 04, 2016. The recall was issued by FDA (recall ID Z-0827-2016).
Why was the Evita Infinity V500 Ventilator; Babylog Infinity VN500… recalled?
Recalled for a safety or quality concern — see details.
What should I do if I have the Evita Infinity V500 Ventilator; Babylog Infinity VN500…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Evita Infinity V500 Ventilator; Babylog Infinity VN500…?
The official FDA recall record is available here. Always verify recall details with the official source.

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