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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet CO2 analyzer

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  Class 2 Device Recall Maquet CO2 analyzer see related information
Date Initiated by Firm January 12, 2015
Date Posted February 27, 2015
Recall Status1 Terminated 3 on May 15, 2017
Recall Number Z-1224-2015
Recall Event ID 70224
510(K)Number K123149  
Product Classification Apparatus, gas-scavenging - Product Code CBN
Product Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Code Information Serial Numbers:  9592 9604 9606 9608 9609 9610 9611 9612 9616 9617 9618 9619 9620 9621 9625 9626 9627 9636 9643 9645 9646 9647 9648 9649 9650 9651 9652 9653 9654 9655 9656 9657 9658 9659 9660 9661 9662 9664 9666 9667 9668 9669 9670 9671 9674 9676 9677 9678 9679 9680 9681 9682 9683 9684 9686 9687 9689 9690 9692 9697 9698 9702 9706 9708 9709 9712 9716 9718 9720 9721 9727 9732 9739 9747 9748 9752 9754 9755 9756 9757 9760 9763 9764 9765 9767 9770 9772 9774 9775 9777 9779 9782 9784 9785 9787 9788 9789 9793 9794 9795 9797 9799 9801 9802 9804 9805 9806 9808 9809 9810 9812 9813 9814 9815 9816 9817 9818 9819 9820 9821 9822 9823 9824 9825 9826 9827 9828 9829 9830 9831 9832 9833 9834 9836 9837 9838 9839 9840 9841 9860 9887 9891 9893 9894 9901 9902 9907 9908 9909 9916 9917 9922 9925 9934 9935 9937 9939 9941 9945 9946 9953 9954 9958 9959 9961 9963 9967 9991 10003 10004 10005 10006 10007 10008 10009 10010 10011 10012 10013 10018 10019 10020 10021 10022 10023 10024 10027 10029 10032 10060 10064 10070 10078 10079 10080 10082 10083 10084 10085 10086 10091 10092   
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
Manufacturer Reason
for Recall		 A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.
FDA Determined
Cause 2		 Device Design
Action Maquet sent an Urgent Product Recall Medical Device Action Field Removal Letter dated 1/12/2015 via FedEx.
Quantity in Commerce 486 units
Distribution Worldwide distribution - USA nationwide, Austria, Australia, Belgium, Chile, Canada, Colombia, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Italy, Japan, Libya, Netherlands, Norway, Panama, Peru, Portugal, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
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 = CBN and Original Applicant = MAQUET CRITICAL CARE AB
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