Z-1440-2014 Class I Terminated
FDA device recall Z-1440-2014 was initiated by Draeger Medical Systems, Inc. on March 5, 2014 and is designated Class I. 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 unplu… The recall status is terminated (terminated October 31, 2014). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2014
- Initiation Date
- March 5, 2014
- Termination Date
- October 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
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.
Distribution Pattern
USA Nationwide Distribution in the states of WI and NY.
Code Information
Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005