Recall Z-1440-2014— Draeger Medical Systems, Inc.

Name: FDA recall Z-1440-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class I · Terminated

Class I FDA medical device recall by Draeger Medical Systems, Inc., initiated 2014-03-05, terminated 2014-10-31. It names one FDA 510(k) clearance: K103625. Product: Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833. 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..

Recalling firm: Draeger Medical Systems, Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-03-05
Terminated: 2014-10-31
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K103625 — OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICEDraeger Medical Systems, Inc.·cleared 2011-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.