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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 Systemsee related information
Date Initiated by FirmJuly 08, 2008
Date PostedSeptember 23, 2008
Recall Status1 Terminated 3 on December 23, 2008
Recall NumberZ-2442-2008
Recall Event ID 49117
510(K)NumberK041223 
Product Classification Ventilator - Product Code CBK
ProductSERVO-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 ContactJamie 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
ActionUrgent - 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 Commerce122 units (SERVO-i and SERVO-s) units in United States
DistributionWorldwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CBK
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