The Recall Desk
HighFDA (Devices)·Z-0871-2022·Announced 2022-04-13

Draeger Babylog VN500 Ventilators Recalled for Cybersecurity Vulnerability

Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.

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 recall of a critical medical device (ventilator) for vulnerable neonatal and pediatric populations. The cybersecurity vulnerability poses a potential risk of harm to patients, though no injuries or illnesses have been reported.

Plain-English summary

Draeger Medical, Inc. is recalling the Babylog VN500 ventilator with Software 2.51.01 and lower versions (Catalog Number 8417400). The ventilators are intended for ventilation of neonatal patients weighing 0.4 kg to 10 kg and pediatric patients weighing 5 kg to 20 kg. A total of 13,687 units have been distributed, with 2,987 units in the United States. All lots and serial numbers are affected (UDI: 04048675250418).

The ventilators are not equipped against potential cybersecurity threats. Draeger Medical, Inc. has initiated this recall to address the cybersecurity vulnerability.

Healthcare facilities and clinicians using the Babylog VN500 ventilator should contact Draeger Medical, Inc. for information regarding remediation or replacement options. Patients and providers with questions or wishing to report adverse events should contact Draeger Medical, Inc. or the FDA.

The recalled product

Product
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
Manufacturer
Draeger Medical, Inc.
Category
Medical Device — Ventilators
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: 04048675250418

Distribution

Distributed nationwide across the United States.

Related recalls

Same category