FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Evita XL Critical Care Ventilator. Continuous (Respirator)
- Recall number
- Z-2327-2008
- Recalling firm
- Draeger Medical, Inc.
- Product
- Evita XL Critical Care Ventilator. Continuous (Respirator)
- Status
- Terminated
- Initiated
- 2008-07-02
- Posted
- 2008-09-20
- Terminated
- 2009-09-01
- Reason
- audible power failure alarm was not enunciated at the required volume
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.
- Quantity
- 83 units
- Distribution
- The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.
- Lot, serial or model codes
- Catalog number 8414900. Products recalled had the CO2 Carrier Printed Circuit Board (PCB) part number 8306611 replaced between January 2005 and May 2008. The serial number for the affected CO2 Carrier PCBs have a prefix of ARW, ARX, or ARY.
- 510(k) numbers
- ["K051263"]
- 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