Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 11/5/2008
Class:ll
PRODUCT
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02 ultrasound system with onscreen display, Recall # Z-0086-2009
REASON
Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on August 19, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
169 units total
DISTRIBUTION
Nationwide, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal, Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary, Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela, Puerto Rico, Brazil and Japan