Draeger Medical recalls Evita V500 ventilators with CO2 measurement software 2.51 or lower. This version may cause brief pauses in breathing support for up to 8 seconds, potentially affecting patient safety.
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 Evita V500 ventilators with CO2 measurement software version 2.51 or lower. This software version can cause brief pauses in ventilation for up to 8 seconds, which may lead to loss of positive airway pressure and could be harmful to patients.
The software version 2.51 and lower with CO2 measurement option may cause the ventilator to restart briefly, leading to a temporary stop in ventilation for about 8 seconds. This can result in loss of positive airway pressure (PEEP), which is critical for maintaining proper breathing support in patients.
Healthcare providers using Evita V500 ventilators with CO2 measurement software version 2.51 or lower are affected. Patients receiving ventilation support with this specific software version are at risk of brief breathing interruptions.
Check if your Evita V500 ventilator has the CO2 measurement option and software version 2.51 or lower. The product is identified by catalog number 8416400.
Verify your ventilator's software version by checking the device settings or documentation. If it is 2.51 or lower with CO2 measurement option, it is affected.
No, this recall specifically applies to Evita V500 ventilators with the CO2 measurement option and software version 2.51 or lower.
The ventilator may restart briefly, causing a temporary stop in ventilation for about 8 seconds, which can lead to loss of positive airway pressure (PEEP).
Check if your Evita V500 ventilator has the CO2 measurement option and software version 2.51 or lower. The product is identified by catalog number 8416400.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0108-2022 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-0108-2022 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.
