The Recall Desk
HighFDA (Devices)·Z-0108-2022·Announced 2021-10-20

Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss

Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.

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: FDA Class II medical device recall involving a software defect that may cause temporary loss of mechanical ventilation support. No illnesses or injuries are reported in the source material, classifying this as a risk-of-harm scenario without documented patient incidents.

Plain-English summary

The Evita V500 ventilator, manufactured by Draeger Medical, is used to support breathing in adult, pediatric, and neonatal patients. A software defect in versions 2.51 and lower with the installed CO2 measurement option may cause the ventilator to restart unexpectedly.

When a restart occurs, the ventilator briefly stops providing ventilation and loses PEEP (positive end-expiratory pressure) for approximately 8 seconds. This interruption in breathing support poses a risk to patients who depend on mechanical ventilation.

Approximately 6,797 units have been distributed nationwide. The defect is associated with specific software versions and affects models with the CO2 measurement option installed.

Healthcare facilities using affected units should verify their software version and contact Draeger Medical for guidance on available patches or firmware updates to resolve this issue.

The recalled product

Product
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Manufacturer
Draeger Medical, Inc.
Category
Medical Device — Respiratory / Ventilator
Hazard
  • software-defect
  • device-restart
  • loss-of-ventilation

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)

  • Software 2.51 and Lower

Distribution

Distributed nationwide across the United States.

Related recalls

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