Draeger Medical recalls Babylog VN600 ventilators from 2019-2020 due to software problems causing incorrect oxygen alarms and ventilation restarts. Affected units may need repair or replacement.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Take action
Contact the company
📍Recalling firmDraeger Medical, Inc.3135 Quarry Rd · Telford, PA 18969-1042
“Draeger Babylog VN600 Ventilator Software Issues: Risk of Incorrect Oxygen Levels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62769-draeger-babylog-vn600-ventilator-software-issues-risk-of-incorrect-oxygen. Based on FDA recall #Z-1692-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1692-2021%22&limit=1).
The FDA announced on April 16, 2021, that Draeger Medical, Inc. recalled Critical Care Ventilators, specifically the Babylog VN600 with catalog number 8422200, due to software-related hazards. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: Draeger Medical
Product: Critical Care Ventilator
Catalog Number: 8422200
Model: Babylog VN600
The hazard
The recall addresses three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600, and Babylog VN800: restart of the ventilation unit, incorrect FiO2 high and low alarms, and suspension of SmartCare/PS weaning. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Draeger Medical, Inc. has 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 Philips Respironics Trilogy Evo O2 Ventilator Software Issue (March 2, 2026).
How to tell if you have this one
Check for Babylog VN600 ventilators with catalog number 8422200 made between January 2019 and March 2020. The product is used for treating patients needing respiratory support.
Brand
Draeger Medical
Category
Medical device
FDA recall event · 4 products
All 4 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
Terminated
Distribution
US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
Recall number
Product, codes & lots
Quantity
Z-1690-2021
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.; All lots/serial numbers manufactured from 1/1/2019-3/31201
34 units
Z-1691-2021
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.; All lots/serial numbers manufactured from 1/1/2019-3/31201
18 units
Z-1692-2021
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.; All lots/serial numbers manufactured from 1/1/2019-3/31201
2 units
Z-1693-2021
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.; All lots/serial numbers manufactured from 1/1/2019-3/31201
12 units
Based on the official FDA remedy
What to do — step by step
Check Ventilator Model
Identify if your ventilator is a Babylog VN600 with catalog number 8422200 made between January 2019 and March 2020.
Contact Manufacturer
Reach out to Draeger Medical for repair or replacement options as the recall remedy is not specified in the record.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Maryland, Mississippi, New York, Pennsylvania, Texas, Washington.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1692-2021 (April 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1692-2021 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.