Draeger Medical recalls Babylog VN500 ventilators with CO2 measurement software 2.51 or lower. This version may cause brief pauses in breathing support for neonatal patients, risking loss of pressure support for up to 8 seconds.
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Draeger Medical is recalling Babylog VN500 ventilators with CO2 measurement software version 2.51 or lower. These ventilators may briefly stop breathing support for up to 8 seconds, which could be dangerous for newborns and infants.
The software version 2.51 and lower may cause the ventilator to restart, leading to a brief stop in breathing support. This can cause loss of pressure support for about 8 seconds, which might be harmful for newborns and infants who require precise ventilation.
Neonatal and pediatric patients using ventilators with software version 2.51 or lower. Healthcare providers and parents of infants under 10 kg who use these ventilators are most at risk.
Check if your Babylog VN500 ventilator has the CO2 measurement option and software version 2.51 or lower. This model is intended for neonatal patients weighing up to 10 kg and pediatric patients up to 20 kg.
Contact Draeger Medical to get the latest software version for your ventilator.
No, this recall specifically applies to Babylog VN500 ventilators with the CO2 measurement option and software version 2.51 or lower.
The pause in ventilation can last up to 8 seconds.
Contact Draeger Medical to update the software to a newer version that resolves this issue.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0109-2022 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-0109-2022 from Draeger 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.
