Class 2 Device Recall V5M TEE Transducer

• Date Initiated by Firm: August 28, 2009
• Date Posted: February 22, 2011
• Recall Status: Terminated on March 29, 2011
• Recall Number: Z-1392-2011
• Recall Event ID: 53691
• 510(K)Number: K082142
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at software version VA10, VA10A, VA10B, VA10C, VA15, VA15A, VA15B, VA16 or VA16A, manufactured by Siemens Medical Solutions, Mountain View, CA. Multipurpose mobile software controlled diagnostic ultrasound system and on-screen display for thermal and mechanical indices related to bio-effect mechanisms. Its function is to acquire primary or secondary ultrasound echo data. The V5Ms is a multi frequency, multiplane, phased sector array transducer. It can be introduced into the esophagus to obtain images of the heart structure.
• Code Information: Model numbers: -10041461: Acuson S2000; -8263703: V5Ms Transducer; -10041524: S2000Cardiac Imaging and Quantification; -10436394: S2000 CV Imaging and Quantification; -10041525: S2000 Advanced Cardiac Analysis; -10041501: S2000 Cardiac Application Module; -10042966: S2000 Cardiac Application Module Upgrade; -10042990: S2000 Cardiac Application Module- No Physio Upgrade; -10042991: S2000 Card Application Module with Physio Upgrade; -100442992: S2000 Card App Module only Upgrade
• FEI Number: 2936884
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 1230 Shorebird Way; P.O. Box 7393; Mountain View CA 94043
• For Additional Information Contact: Shiela Pickering; 650-694-5398
• Manufacturer Reason for Recall: If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees Centigrade.
• FDA Determined Cause: Software design
• Action: Siemens sent a Customer Safety Advisory Notification letter on August 28, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their local Customer Service Engineer would install a software update as soon as it becomes available. Customers were instructed to pass the Customer Safety Advisory Notification letter to all who need to be aware of these issues until the corrective action is completed. For questions regarding this recall call 650-969-9112 or 800-422-8766.
• Quantity in Commerce: 97 units
• Distribution: Worldwide Distribution - USA (nationwide) and internationally to Canada, China, Czech Republic, Denmark, Germany, Great Britian, Hong Kong, Indonesia, Italy, Japan, Norway, Poland, Portugal, Russian Federation, Singapore, South Korea, Taiwan, and Turkmenistan.
• 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