The Recall Desk
HighFDA (Devices)·Z-1692-2021·Announced 2021-06-09

Draeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects

Draeger Medical is recalling Babylog VN600 ventilators due to three software issues: unexpected unit restarts, incorrect oxygen-level alarms, and failure of the automated weaning protocol. These defects could affect patient care and safety.

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 recall affecting critical care ventilators with three separate software defects (unexpected restart, incorrect oxygen-level alarms, and automated weaning protocol suspension). The source material does not report any illnesses or injuries. These are risk-of-harm products where potential harms have not yet been reported, meeting the criterion for High severity.

Plain-English summary

Draeger Medical, Inc. is recalling the Babylog VN600 critical care ventilator (catalog number 8422200). The device is used to provide temporary or long-term respiratory support to patients requiring respiratory assistance for various medical conditions.

The recall addresses three separate software defects: the ventilator may unexpectedly restart during operation, the FiO2 (oxygen level) high and low alarms may display incorrect readings, and the SmartCare/PS automated weaning protocol may suspend unexpectedly. Affected units were manufactured from January 1, 2019 through March 31, 2021.

The recalled ventilators were distributed nationwide to facilities in Pennsylvania, Texas, Maryland, Florida, Washington, Mississippi, and New York. Affected healthcare providers and facilities should contact Draeger Medical, Inc. immediately for instructions. Patients currently on these ventilators should discuss any concerns with their healthcare provider.

The recalled product

Product
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - 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 — Ventilator / Respiratory Support
Hazard
  • device-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