30

Mar

2011

Cl ll V5M TEE Transducer with ACUSON S2000

0

Company: Siemens Medical Solutions
Date of Enforcement Report 3/30/2011
Class ll:

PRODUCT
V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at. 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. 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. Recall # Z-1392-2011

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.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on August 28, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
131 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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