Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption
A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a documented software defect causing ventilator restart and brief ventilation interruption. No illnesses or injuries have been reported, but the hazard poses direct risk to neonatal and pediatric patients dependent on mechanical ventilation.
Plain-English summary
Draeger Medical, Inc. is recalling 2,169 units of the Babylog VN500 Ventilator with Installed CO2 Measurement Option (Catalog Number: 8417400) due to a software defect in version 2.51 and lower.
The defect may cause the ventilator to restart, resulting in a brief cessation of ventilation and loss of PEEP (positive end-expiratory pressure) for approximately 8 seconds. This interruption in ventilation support poses a risk to patients depending on the device for respiratory support.
The affected ventilators are intended for neonatal patients weighing 0.4 kg to 10 kg (0.88 lbs to 22 lbs) and pediatric patients weighing 5 kg to 20 kg (11 lbs to 44 lbs). These units were distributed nationwide.
Healthcare providers and facility managers using this ventilator should contact Draeger Medical, Inc. for information about a firmware update or other corrective measures to address the software defect.
The recalled product
- Product
- Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of 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.
- Affected units
- 2,169
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.
Part of a larger recall action
This product is one of 2 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Draeger Medical, Inc.
See all →- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- SevereDräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns
FDA (Devices) · 2024-04-24
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighDraeger Babylog VN500 Ventilators Recalled for Cybersecurity Vulnerability
FDA (Devices) · 2022-04-13
- HighBabylog VN800 Critical Care Ventilator Recalled for Software Malfunctions
FDA (Devices) · 2021-06-09
- HighDraeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects
FDA (Devices) · 2021-06-09
- SevereDraeger Recalls Optional PS500 Power Supply Units for Ventilators
FDA (Devices) · 2015-12-30
- SevereDraeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect
FDA (Devices) · 2016-03-02
- HighDraeger Evita V500 Ventilator Cybersecurity Vulnerability Affects Patient Safety
FDA (Devices) · 2022-04-13