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U.S. Department of Health and Human Services

Class 2 Device Recall Evita 4 Continuous Ventilator

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  Class 2 Device Recall Evita 4 Continuous Ventilator see related information
Date Initiated by Firm May 07, 2003
Date Posted June 27, 2003
Recall Status1 Terminated 3 on January 20, 2006
Recall Number Z-0954-03
Recall Event ID 26388
510(K)Number K010093  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Evita 4 Continuous Ventilator
Code Information Catalog numbers 4116640 and 8412980
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969
For Additional Information Contact Michael Kelhart
800-523-6817 Ext. 2349
Manufacturer Reason
for Recall		 software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
FDA Determined
Cause 2		 Other
Action The recalling firm issued recall letters to the accounts dated 5/7/03.
Quantity in Commerce 806 units
Distribution The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDIZINTECHNIK GMBH
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