Draeger Medical recalls Babylog VN600 ventilators from 2019-2020 due to software problems causing incorrect oxygen alarms 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 VN600 ventilators made between January 2019 and March 2020 because software issues could cause incorrect oxygen level alarms and ventilation restarts. This poses a risk to patients receiving respiratory support.
The ventilator software has three issues: it may restart unexpectedly, give incorrect high/low oxygen alarms, and suspend weaning procedures. These problems could lead to incorrect oxygen delivery to patients, potentially causing harm.
Healthcare facilities using Babylog VN600 ventilators for patient respiratory support are most affected. Patients receiving critical care with these ventilators face the highest risk.
Check for Babylog VN600 ventilators with catalog number 8422200 made between January 2019 and March 2020. The product is used for treating patients needing respiratory support.
Identify if your ventilator is a Babylog VN600 with catalog number 8422200 made between January 2019 and March 2020.
Reach out to Draeger Medical for repair or replacement options as the recall remedy is not specified in the record.
The ventilator software has three issues: it may restart unexpectedly, give incorrect high/low oxygen alarms, and suspend weaning procedures.
The recall does not specify an immediate stop-use action; healthcare facilities should contact Draeger Medical for repair or replacement.
The affected units were manufactured from January 2019 through March 2020.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1692-2021 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-1692-2021 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.
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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.
