The Recall Desk
HighFDA (Devices)·Z-1691-2021·Announced 2021-06-09

Draeger Evita V800 Ventilator Recalled for Multiple Software Defects

Draeger Medical is recalling the Evita V800 critical care ventilator due to three unrelated software defects affecting ventilation delivery and alarm functionality.

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 an FDA Class II medical device recall without reported hospitalizations or injuries. However, it involves risk-of-harm defects in a critical care ventilator where functional failures could result in inadequate respiratory support, meeting the criteria for a High severity rating.

Plain-English summary

Draeger Medical, Inc. is recalling the Evita V800 critical care ventilator, Catalog Number 8422500. This device is used to provide temporary or longer-term respiratory support to patients requiring mechanical ventilation.

Three separate and unrelated software defects have been identified: (1) unexpected restart of the ventilation unit, (2) incorrect FiO2 high and FiO2 low alarms, and (3) SmartCare/PS (SC/PS) suspended weaning functionality. These defects may affect the device's ability to deliver consistent ventilation and provide accurate alarm notifications to clinical staff.

The recall affects 18 units distributed nationwide in Pennsylvania, Texas, Maryland, Florida, Washington, Mississippi, and New York. All ventilators manufactured between January 1, 2019 and March 31, 2021 are included. Healthcare facilities and users of this ventilator should immediately contact Draeger Medical for instructions on how to address the identified defects.

The recalled product

Product
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Manufacturer
Draeger Medical, Inc.
Category
Medical Device — Critical Care / Ventilator
Hazard
  • device-restart
  • alarm-failure
  • software-malfunction

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 manufactured from 1/1/2019-3/31201

Distribution

Distributed nationwide across the United States.

Related recalls

Same category