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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 SERVOi see related information
Date Initiated by Firm May 23, 2006
Date Posted January 25, 2007
Recall Status1 Terminated 3 on April 11, 2008
Recall Number Z-0372-2007
Recall Event ID 37089
510(K)Number K010925  
Product Classification ventilator - Product Code CBK
Product Ventilator System SERVO-i V3.1 PC1777
Maquet Critical Care
Code Information Article # 64-87-800 Serial numbers 02400 - 03300
Recalling Firm/
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information Contact Jamie Yieh
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
Action Maquet 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 Commerce 1, 970 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.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = SIEMENS ELEMA AB