FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Evita 4 Continuous Ventilator
- Recall number
- Z-0954-03
- Recalling firm
- Draeger Medical, Inc.
- Product
- Evita 4 Continuous Ventilator
- Status
- Terminated
- Initiated
- 2003-05-07
- Posted
- 2003-06-27
- Terminated
- 2006-01-20
- Reason
- software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
- Root cause
- Other
- Action
- The recalling firm issued recall letters to the accounts dated 5/7/03.
- Quantity
- 806 units
- Distribution
- The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada.
- Lot, serial or model codes
- Catalog numbers 4116640 and 8412980
- 510(k) numbers
- ["K010093"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28