FDA Medical Device Recalls (openFDA)
Draeger Medical Systems, Inc.: Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
- Recall number
- Z-1440-2014
- Recalling firm
- Draeger Medical Systems, Inc.
- Product
- Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
- Status
- Terminated
- Initiated
- 2014-03-05
- Posted
- 2014-04-10
- Terminated
- 2014-10-31
- Reason
- The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
- Root cause
- Process control
- Action
- Drager sent an Urgent Medical Device Recall letter dated February 2014 to affected customers. The letter identified the affected device, problem and actions to be taken. The notification directed customers to perform manual ventilation in the event of a failure. Drager plans to repair the affected devices free of charge. If you have any questions regarding the Recall letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
- Quantity
- 3
- Distribution
- USA Nationwide Distribution in the states of WI and NY.
- Lot, serial or model codes
- Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005
- 510(k) numbers
- ["K103625"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 2510954
- 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