Class 2 Device Recall Evita 4 Continuous Ventilator

• Date Initiated by Firm: May 07, 2003
• Date Posted: June 27, 2003
• Recall Status: Terminated 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
• FEI Number: 2517967
• 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: 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