Draeger Medical recalls Evita V500 ventilators with software 2.51.01 and lower due to cybersecurity vulnerabilities. All units are affected; no specific remedy is provided in the recall notice.
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Draeger Medical is recalling all Evita V500 ventilators with software version 2.51.01 and older because they have cybersecurity weaknesses that could be exploited. This affects hospitals and medical facilities using these ventilators for adult, pediatric, and neonatal patients.
The ventilators are vulnerable to cybersecurity threats, which could allow unauthorized access to the device's systems. This might lead to potential disruptions in patient care if hackers manipulate the ventilator settings.
Hospitals and medical facilities using Evita V500 ventilators with software 2.51.01 or older are affected. Patients receiving ventilation care in these settings are at risk if the ventilators are compromised by cyber threats.
Check if your Evita V500 ventilator has software version 2.51.01 or lower. All units are affected, as the recall covers all lots and serial numbers.
Verify your ventilator's software version to determine if it is 2.51.01 or lower.
The recall notice does not specify any remedy or fix for the cybersecurity vulnerability.
All Evita V500 ventilators with software version 2.51.01 or lower are affected, as the recall covers all lots and serial numbers.
The recall does not provide a specific action to stop using the ventilator; the hazard is described as a cybersecurity risk without immediate stop-use instructions.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-0870-2022 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-0870-2022 from Draeger. 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.
