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U.S. Department of Health and Human Services

Class 2 Device Recall SERVOi Ventilator System

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  Class 2 Device Recall SERVOi Ventilator System see related information
Date Initiated by Firm July 08, 2008
Date Posted September 23, 2008
Recall Status1 Terminated 3 on December 23, 2008
Recall Number Z-2442-2008
Recall Event ID 49117
510(K)Number K041223  
Product Classification Ventilator - Product Code CBK
Product SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Code Information Article number 64 87 800 Serial numbers: 34034, 34035, 34050, 34052, 34053, 34054, 34058,  34060 through 34083, 34085, 34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295, 34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230, 34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360, 34376, 34384, 34390, 34427, 34490, and 34530.
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information Contact Jamie Yieh
732-667-1896
Manufacturer Reason
for Recall		 Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
FDA Determined
Cause 2		 Employee error
Action Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
Quantity in Commerce 122 units (SERVO-i and SERVO-s) units in United States
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.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = MAQUET CRITICAL CARE AB
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