Draeger Medical, Inc. Evita 4 Continuous Ventilator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Evita 4 Continuous Ventilator
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
Catalog numbers 4116640 and 8412980
Products Sold
Catalog numbers 4116640 and 8412980
Draeger Medical, Inc. is recalling Evita 4 Continuous Ventilator due to software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
Recommended Action
Per FDA guidance
The recalling firm issued recall letters to the accounts dated 5/7/03.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026