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U.S. Department of Health and Human Services

Class 2 Device Recall Evita XL Continuous Ventilator

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  Class 2 Device Recall Evita XL Continuous Ventilator see related information
Date Initiated by Firm July 02, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on September 01, 2009
Recall Number Z-2327-2008
Recall Event ID 48963
510(K)Number K051263  
Product Classification Continuous Ventilator - Product Code CBK
Product Evita XL Critical Care Ventilator. Continuous (Respirator)
Code Information Catalog number 8414900. Products recalled had the CO2 Carrier Printed Circuit Board (PCB) part number 8306611 replaced between January 2005 and May 2008. The serial number for the affected CO2 Carrier PCBs have a prefix of ARW, ARX, or ARY.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Technical Support
800-543-5047
Manufacturer Reason
for Recall		 audible power failure alarm was not enunciated at the required volume
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.
Quantity in Commerce 83 units
Distribution The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.
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 MEDICAL AG & CO. KGAA
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