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U.S. Department of Health and Human Services

Class 2 Device Recall SERVOi

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 Class 2 Recall
SERVOi
see related information
Date Posted January 25, 2007
Recall Status1 Terminated on April 11, 2008
Recall Number Z-0372-2007
Recall Event ID 37089
Premarket Notification
510(K) Number
K010925 
Product Classification Ventilator, Continuous, Facility Use - 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/
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
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 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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