Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 11/5/2008
Class:ll
PRODUCT
Acuson X300 ultrasound systems, ultrasound system with onscreen display. Model numbers 10037409, 10038837, 10348531. Potentially affected, but no volume currently: 10132987, 10133170, 10348532, 10348533, Recall # Z-0111-2009
REASON
Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.
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
72 units
DISTRIBUTION
Nationwide, France, Colombia, Poland, Taiwan, Saudi Arabia, Austria, Malaysia, India, Czech Republic, Croatia, Argentina, Venezuela, Italy, Philippines, Mauritius, Spain, Bolivia, Germany, Ukrain, Russia, United Kingdom, Brazil, South Africa and Canada