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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Critical Care Ventilator System

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 Class 2 Recall
Maquet Critical Care Ventilator System
see related information
Date Posted February 10, 2007
Recall Status1 Terminated on March 23, 2009
Recall Number Z-0379-2007
Recall Event ID 37099
Premarket Notification
510(K) Number
K010925 
Product Classification Ventilator, Continuous, Facility Use - 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, New Jersey 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 2
DESIGN: Device Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = SIEMENS ELEMA AB
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