Class 2 Device Recall Evita XL Continuous Ventilator

• Date Initiated by Firm: July 02, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated 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: 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