Class 2 Device Recall V5Ms Transesophageal transducers

• Date Initiated by Firm: August 13, 2014
• Date Posted: September 03, 2014
• Recall Status: Terminated on March 06, 2015
• Recall Number: Z-2571-2014
• Recall Event ID: 69138
• 510(K)Number: K121807
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: V5Ms Transesophageal transducers;; ; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
• Code Information: Model numbers 8264577 and 8263703; Serial numbers: US: 33707625 32807460 34507747 42208166 S34707777 32907477 33007494 33307538 33507577 33507584 33707612 34107671 34707781 40908018 41508085 41608100 41908126 41908129 S34607757 S34907818 33907638 33907642 34807802 33007497 34207690 34307704 34607760 40607983 41808117 41908127 35107862 35107863 40107882 40407947 S34307696 33707631 34207694 33007487 41508082 41608089 34707771 41708101 33207509 33207519 33207522 33707622 34907824 35107872 40107896 42008137 33207520 41708109 S34607755 33307537 33607596 33707619 34607768 41808119 33707630 42008136 40407946 34207680 34607762 40808002 41008037 41708108 S33207505 33507578 41108046 41308062 42008132 34307703 34707778 40307937 40407951 40808007 41908128 40207906 32907474 33307539 34607758 35107875 40908017 41308054 41508088 41508080 41508087 33507576 33607590 33707621 40407958 40607982 41008032 41808118 42208161 42208163 41408065 33207513 33407545 33507575 33707615 33707624 34207693 34707785 35107867 35107868 40307938 40707986 S33007483 S33707609 40307940 42208165 41108044 42108156 42108157 41508076 42008133 34307712 34007659 32807451 32807459 34207678 34307702 34707787 34907832 40607979 40607980 41808120 41908125 32807454 33707614 41008033 34407716 34707776 S33007481 S34307698 S34407722 33507569 34607764 34907840 40707991 40407944 33907651 33907633 34807811 34907838 34207695 41108041 S34307700 33407553 35007855 40407949 40307924 40307927 S33307527 32907479 33007498 33507582 33907635 34007662 34707782 34907831 40407955 41608096 40707988 ROW: 35007853 40807999 34307711 40607974 40207909 34607767 40307933 33407548 40107885 34507743 33907648 42108150 40207910 33607599 32907471 35107859 40707992 41608093 40507963 34807806 40107887 41008038 33907636 34807807 41008034 34807810 S34007656 S34607750 33707607 33507572 34807805 42108154 40207913 42108144 40807998 42108145 33907640 33207510 40707985 40107900 34707779 40707984 35007847 40107890 40507966 41108042 40207903 42008134 41508081 34407730 40307932 40908016 40207907 40808005 34807795 33607587 34007664 34807809 40207912 33907643 33907634 34707790 40507971 41708106 40407943 41408068 33507581 34407726 40307935 33507585 42008139 34607751 S34307697 34407725 S32907463 S33407560 33507574 40507962 33607592 33207515 40307925 S34507742 41408073 S40207904 S33307531 40707990 40707996 34707770 33507568 40607977 35007857 40707995 S35007846 S34707775 S34907821 40107884 S34307699 S34607748 34007665 41408072 S33707608 S33407549 34807797 42108155 S32907466 40307929 41008027 40207908 S33407561 33007486 S34907822 34407718 S33007485 S33307532 41308056 40307926 S33007488 41208048 S40207902 34007660 33607600 33507571 S33907653 41608099 S34507738 S33507570 34307705 34807808 40207922 34507745 34307714 33507566 40307923 41208051 33407543 42208164 41708107 40808009 40507970 40808010 33207514 40908019 40207921 41808116 S34607753 41608098 41408066 41908122 41908123 34507746 40107881 40507968 33407556 35207880 34407732 41008030.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 685 E Middlefield Rd; Mountain View CA 94043-4045
• For Additional Information Contact: Sheila Pickering; 650-417-8185
• Manufacturer Reason for Recall: Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens sent a Customer Safety Advisory notification to all affected customers on August 13, 2014. The notification identified the product, the problem, and the action to be taken by the customer. Customers were advised that if they notice any damage or wear on their transducer, or if the transducer fails to pass the leakage current test, immediately discontinue use of the transducer and contact their local Customer Service Engineer. If they have any questions, customers should contact their local service support person for information regarding timelines and status. Customers were instructed to share this information with all personnel within their organization who need to be aware of this issue. For questions regarding this recall call 650-417-8185.
• Quantity in Commerce: 321 units
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Bolivia, Brazil, Canada, China, Columbia, France, Germany, Great Britain, India, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Slovak Republic, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand,and United Arab Emirates.
• 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 = ITX and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.