Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Evita V500 Ventilator with Software 2.51.01 and Lower - intended Recalled by Draeger Medical, Inc. Due to Cybersecurity Improvement Action-not equipped against potential cyber security...

Date: February 14, 2022
Company: Draeger Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Draeger Medical, Inc. directly.

Affected Products

Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400

Quantity: 24,337 (10,728 units US)

Why Was This Recalled?

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Draeger Medical, Inc.

Draeger Medical, Inc. has 78 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report