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
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Product | Evita 4 Continuous Ventilator |
Code Information |
Catalog numbers 4116640 and 8412980 |
Recalling Firm/ Manufacturer |
Draeger Medical, Inc. 3135 Quarry Rd Telford PA 18969
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CBK
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