Devices

Device Recall V5M TEE Transducer

Model / Serial
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 Classification
Radiology Devices
Device Class
2
Implanted device?
No
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 Description
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.
Manufacturer
Siemens Medical Solutions USA, Inc.
1 Event
- Recall of Device Recall V5M TEE Transducer

Manufacturer

Siemens Medical Solutions USA, Inc.

Manufacturer Address
Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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