Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
FDA device recall Z-1440-2014 · posted 2014-04-10 · Terminated
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- Reason for recall
- 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.
- Action taken
- 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).
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTL
- Quantity affected
- 3
- Distribution
- USA Nationwide Distribution in the states of WI and NY.
- Date initiated
- 2014-03-05
- Date posted
- 2014-04-10
- Date terminated
- 2014-10-31
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE (K103625) | Draeger Medical Systems, Inc. | 2011-10-06 |