UnratedMedical device recall · FDA · Published February 14, 2022
Draeger Evita V50: Cybersecurity Risk in Ventilators - Recall Notice
Draeger Medical recalls Evita V500 ventilators with software 2.51.01 and lower due to cybersecurity vulnerabilities. All units are affected; no specific remedy is provided in the recall notice.
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Take action
Contact the company
📍Recalling firmDraeger Medical, Inc.3135 Quarry Rd · Telford, PA 18969-1042
✎ GovInfoNow plain-language explainer
Draeger Medical is recalling all Evita V500 ventilators with software version 2.51.01 and older because they have cybersecurity weaknesses that could be exploited. This affects hospitals and medical facilities using these ventilators for adult, pediatric, and neonatal patients. Read more at govinfonow.com/recall/61145-draeger-evita-v50-cybersecurity-risk-in-ventilators-recall-notice.
“Draeger Evita V50: Cybersecurity Risk in Ventilators - Recall Notice.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61145-draeger-evita-v50-cybersecurity-risk-in-ventilators-recall-notice. Based on FDA recall #Z-0870-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0870-2022%22&limit=1).
The FDA announced on Feb. 14, 2022, that Draeger Medical, Inc. is recalling Evita V500 ventilators due to cybersecurity vulnerabilities. The agency stated the devices are not equipped against potential cyber security threats.
How to tell if you have it
Brand: Draeger
Product: Evita V500 Ventilator with Software 2.51.01 and Lower
Catalog Number: 8416400
UDI: 04048675042266
The hazard
According to the FDA, the recall addresses a cybersecurity improvement action because the devices are not equipped against potential cyber security threats.
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: Risk of Ventilator Failure (May 7, 2026) and the Philips Respironics Trilogy EV300 Ventilator Software Update Risk (March 2, 2026).
How to tell if you have this one
Check if your Evita V500 ventilator has software version 2.51.01 or lower. All units are affected, as the recall covers all lots and serial numbers.
Brand
Draeger
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
Terminated
Distribution
US Nationwide
Recall number
Product, codes & lots
Quantity
Z-0870-2022
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400; All Lots/Serial Numbers. UDI: 04048675042266
24,337 (10,728 units US)
Z-0871-2022
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; All Lots/Serial Numbers. UDI: 04048675250418
13,687 (2,987 units US)
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your ventilator's software version to determine if it is 2.51.01 or lower.
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 terminated this recall 2.9 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-0870-2022 (February 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0870-2022 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.