Draeger Medical recalls Evita V600 ventilators (2019-2020 models) 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 Evita V600 ventilators that have software issues causing incorrect oxygen level alarms and potential ventilation restarts. This could lead to improper patient oxygen treatment if not fixed.
The ventilators have three software problems: 1) The unit may restart unexpectedly, 2) Oxygen level alarms may show incorrect high or low readings, and 3) The weaning process may be suspended prematurely. These issues could lead to improper oxygen treatment for patients.
Healthcare facilities using Evita V600 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 Evita V600 ventilators with catalog number 8422300 manufactured between January 1, 2019, and March 31, 2020. The product is used for treating patients needing respiratory support.
Look for signs of unexpected restarts or incorrect oxygen level alarms on the ventilator display.
Reach out to Draeger Medical for repair or replacement options for affected units.
The Evita V600 has three software issues: unexpected restarts, incorrect high and low oxygen alarms, and premature suspension of weaning.
The affected units were manufactured from January 1, 2019, to March 31, 2020.
No, but you should check for software issues and contact Draeger Medical for repair or replacement.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1690-2021 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-1690-2021 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.
