Siemens Medical Solutions USA, Inc.: 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.

Recall number

Z-1392-2011

Recalling firm

Siemens Medical Solutions USA, Inc.

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.

Status

Terminated

Initiated

2009-08-28

Posted

2011-02-22

Terminated

2011-03-29

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K082142"]

PMA numbers

not on file

Product code

ITX

Firm FEI

2936884

Firm city

Mountain View

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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