Draeger Medical recalls Babylog VN800 ventilators from 2019-2020 due to software problems causing incorrect oxygen levels and ventilation restarts. Affected units may need repair or replacement.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Draeger Medical is recalling Babylog VN800 ventilators made between January 2019 and March 2020 because of software issues that could cause incorrect oxygen levels and ventilation restarts. This could lead to serious health risks for patients using the ventilator.
The ventilator software has three separate problems: it may restart unexpectedly, give incorrect high and low oxygen alarms, and suspend weaning procedures. These issues could lead to incorrect oxygen delivery or ventilation disruptions for patients.
Healthcare providers using Babylog VN800 ventilators for patient respiratory support are most at risk. Patients receiving treatment with these ventilators could be affected if the software issues occur.
Check for Babylog VN800 ventilators with catalog number 8422400 manufactured between January 1, 2019, and March 31, 2020. The product is used for treating patients needing respiratory support.
Look for signs of incorrect oxygen levels or unexpected ventilation restarts in the ventilator.
The ventilator software has three issues: it may restart unexpectedly, give incorrect high and low oxygen alarms, and suspend weaning procedures.
The affected units were manufactured from January 1, 2019, to March 31, 2020.
The recall does not specify an immediate stop-use requirement; healthcare providers should monitor for software issues.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1693-2021 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-1693-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
