The Recall Desk
HighFDA (Devices)·Z-1693-2021·Announced 2021-06-09

Babylog VN800 Critical Care Ventilator Recalled for Software Malfunctions

Draeger Medical is recalling critical care ventilators due to software defects causing unexpected unit restarts, incorrect oxygen level alarms, and suspension of weaning therapy. Twelve units were distributed 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 classified this as a Class II recall for a critical care medical device with software malfunctions affecting patient safety. No illnesses or injuries have been reported in the source text. Per the rubric, this constitutes High severity as a risk-of-harm device where injury has not yet been reported.

Plain-English summary

Draeger Medical, Inc. is recalling the Babylog VN800 critical care ventilator (Catalog Number 8422400) and related models (Evita V600, Evita V800, Babylog VN600) due to software defects affecting safe operation. The affected units were manufactured between January 1, 2019 and March 31, 2019.

Three distinct software malfunctions have been documented: the ventilation unit may unexpectedly restart during operation, oxygen concentration alarms (FiO2 high and FiO2 low) may display incorrect values, and the SmartCare/PS weaning assistance feature may suspend therapy without proper clinical indication.

These defects pose a potential risk to patient safety, as ventilator restarts could interrupt respiratory support, incorrect alarms could lead to improper clinical response, and unintended weaning suspension could compromise patient management.

Twelve units have been distributed nationwide. Healthcare facilities should immediately contact Draeger Medical for guidance on device management, remediation, or replacement.

The recalled product

Product
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - 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 / Respiratory
Hazard
  • ventilator-restart
  • alarm-malfunction
  • weaning-suspension

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