Draeger Medical recalls Babylog VN500 ventilators with CO2 measurement software 2.51 or lower. This version may cause brief pauses in breathing support for neonatal patients, risking loss of pressure support for up to 8 seconds.
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Take action
Contact the company
📍Recalling firmDraeger Medical, Inc.3135 Quarry Rd · Telford, PA 18969-1042
“Draeger Babylog VN500 Ventilator Recall: Software 2.51 Risk of Brief Ventilation Cessation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61806-draeger-babylog-vn500-ventilator-recall-software-2-51-risk-of. Based on FDA recall #Z-0109-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2022%22&limit=1).
The FDA announced on September 10, 2021, that Draeger Medical, Inc. is recalling Babylog VN500 Ventilators with the Installed CO2 Measurement Option due to a software hazard. The recall affects 2,169 units distributed nationwide.
How to tell if you have it
Brand: Draeger Medical
Product: Babylog VN500 Ventilator with Installed CO2 Measurement Option
Catalog Number: 8417400
Software: 2.51 and Lower
Quantity: 2,169 units
The hazard
According to the FDA, software version 2.51 and lower may result in a restart of the ventilator, causing a brief cessation of ventilation and loss of PEEP for approximately 8 seconds.
Context
GovInfoNow's records show Draeger Medical, Inc. has had 16 other recalls on record since March 1, 2018. Other recent recalls of similar products include the Draeger Atlan A350XL Anesthesia Workstation Recall (May 7, 2026) and the Draeger VentStar Resus Neo Neonatal Breathing Circuit recall (September 3, 2026).
How to tell if you have this one
Check if your Babylog VN500 ventilator has the CO2 measurement option and software version 2.51 or lower. This model is intended for neonatal patients weighing up to 10 kg and pediatric patients up to 20 kg.
Brand
Draeger Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide
Recall number
Product, codes & lots
Quantity
Z-0108-2022
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400; Software 2.51 and Lower
6,797 units
Z-0109-2022
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; Software 2.51 and Lower
2,169 units
Based on the official FDA remedy
What to do — step by step
Update Software
Contact Draeger Medical to get the latest software version for your ventilator.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0109-2022 (September 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0109-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.