Z-1392-2011

V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and...

Name: Z-1392-2011 V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-08-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-08-28 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 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... on 2009-08-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1392-2011
Status: Terminated
Initiated: 2009-08-28
Posted: 2011-02-22
Terminated: 2011-03-29
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.
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: 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

Product code ITX

K082142Class IIAcuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI / cleared 2008-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)