The Recall Desk
HighFDA (Devices)·Z-0870-2022·Announced 2022-04-13

Draeger Evita V500 Ventilator Cybersecurity Vulnerability Affects Patient Safety

Draeger Medical is recalling Evita V500 ventilators due to cybersecurity vulnerabilities that could potentially compromise device functionality. Affected units require software remediation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a cybersecurity vulnerability in critical life-support equipment. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity rating per the rubric.

Plain-English summary

Draeger Medical, Inc. is recalling the Evita V500 Ventilator (Catalog Number 8416400) with software version 2.51.01 and lower due to cybersecurity vulnerabilities. The recalled units are not adequately equipped to defend against potential cybersecurity threats.

This recall affects 24,337 units globally, with 10,728 units in the United States distributed nationwide. The Evita V500 is intended for ventilation of adult, pediatric, and neonatal patients.

Users should contact Draeger Medical, Inc. for information on available software updates and remediation measures. Healthcare facilities should consult with the manufacturer regarding appropriate next steps for affected devices.

The recalled product

Product
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Manufacturer
Draeger Medical, Inc.
Category
Medical Device — Respiratory Support Equipment
Hazard
  • cybersecurity-vulnerability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots/Serial Numbers. UDI: 04048675042266

Distribution

Distributed nationwide across the United States.

Related recalls

Same category