Class 2 Device Recall Maquet Critical Care Ventilator System

• Date Initiated by Firm: May 23, 2006
• Date Posted: February 10, 2007
• Recall Status: Terminated on March 23, 2009
• Recall Number: Z-0379-2007
• Recall Event ID: 37099
• Product Classification: Ventilator System - Product Code CBK
• Product: Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
• Code Information: Article number 64-87-800---Serial Numbers 14000-22772
• Recalling Firm/ Manufacturer: MAQUET Inc.; 1140 US Highway 22; Bridgewater NJ 08807-2958
• For Additional Information Contact: Jamie Yieh; 908-947-2311
• Manufacturer Reason for Recall: The Connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the Servo-i Ventilator
• FDA Determined Cause: Other
• Action: Maquet Critical Care issued an ''Extended Warranty'' letter on 5/23/2006. On March 13, 2007, Maquet modified its recall strategy and issued a Recall Notification letter accompanied by a Safety Alert letter to all customers with Servo-i ventilators, serial numbers in the 14000-22772 range, with Servo nebulizer installed. The Safety Alert letter provides customers with information on how to identify if the unit is affected, and how to identify if the unit has shown any failures, as well as, any precautions. Firm initiated recall is on-going
• Quantity in Commerce: 2,436 units
• Distribution: Worldwide
• 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.