—#86332

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.

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082142
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-08-28
Posted by FDA: 2011-02-22
Terminated: 2011-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86332. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.