Draeger Medical recalls Evita V800 ventilators from 2019-2020 with software issues that may cause incorrect oxygen levels or ventilation restarts. Affected units require immediate attention to prevent patient harm.
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 V800 ventilators made between January 2019 and March 2020 due to software problems that could cause incorrect oxygen levels or ventilation restarts. This poses a risk to patients receiving respiratory support, as the ventilator might not function properly during critical care.
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 improper oxygen delivery or ventilation failure during patient treatment.
Healthcare facilities using Evita V800 ventilators for patient respiratory support are most at risk. Patients receiving critical care with these ventilators could be affected if the software issues occur.
Check for Evita V800 ventilators with catalog number 8422500 made between January 2019 and March 2020. The product is used for treating patients needing respiratory support.
Identify if your ventilator is an Evita V800 with catalog number 8422500 made between January 2019 and March 2020.
Reach out to Draeger Medical for specific guidance on software updates or corrective actions.
The Evita V800 ventilator has software issues that could cause incorrect oxygen levels or ventilation restarts, potentially leading to patient harm.
Check if your ventilator matches the recall criteria and contact Draeger Medical for specific guidance on next steps.
Yes, patients receiving respiratory support with these ventilators could face risks from incorrect oxygen levels or ventilation restarts.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1691-2021 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-1691-2021 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.
