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U.S. Department of Health and Human Services

Class 2 Device Recall SERVOi

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 Class 2 Device Recall SERVOisee related information
Date Initiated by FirmMay 23, 2006
Date PostedJanuary 25, 2007
Recall Status1 Terminated 3 on April 11, 2008
Recall NumberZ-0372-2007
Recall Event ID 37089
510(K)NumberK010925 
Product Classification ventilator - Product Code CBK
ProductVentilator System SERVO-i V3.1 PC1777 Maquet Critical Care
Code Information Article # 64-87-800 Serial numbers 02400 - 03300
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information ContactJamie Yieh
908-947-2311
Manufacturer Reason
for Recall		Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.
FDA Determined
Cause 2		Other
ActionMaquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.
Quantity in Commerce1, 970 units
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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