Recall Z-1440-2014 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Draeger Medical Systems, Inc.
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
| Date | Apr 10, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| 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 (pres |
| Quantity | 3 |
| Distribution | USA Nationwide Distribution in the states of WI and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE Draeger Medical Systems, Inc., Oct 6, 2011 |