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U.S. Department of Health and Human Services

Class 1 Device Recall Draeger Oxylog 3000 plus ventilators

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 Class 1 Recall
Draeger Oxylog 3000 plus ventilators
see related information
Date Posted April 10, 2014
Recall Status1 Open
Recall Number Z-1440-2014
Recall Event ID 67677
Premarket Notification
510(K) Number
K103625 
Product Classification Ventilator, Emergency, Powered (Resuscitator) - Product Code BTL
Product Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Code Information Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005
Recalling Firm/
Manufacturer
Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969-1042
For Additional Information Contact Customer Support
215-721-5400
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Process Design
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 Dr®ger ventilator please contact Dr®gerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Quantity in Commerce 3
Distribution USA Nationwide Distribution in the states of WI and NY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BTL and Original Applicant = DRAEGER MEDICAL SYSTEMS, INC.
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