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Terminated

Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

FDA Recall Z-1440-2014 · Posted 2014-04-10

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusTerminated
Product CodeBTL
Date Initiated2014-03-05
Date Terminated2014-10-31
Product Quantity3

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.

Firm 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).

Root Cause

Process control

Distribution Pattern

USA Nationwide Distribution in the states of WI and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103625OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICEDraeger Medical Systems, Inc. · 2011-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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