Company: Siemens Medical SolutionsUSA
Date of Enforcement Report 4/20/2011
Class ll:

PRODUCT
Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. Recall # Z-1900-2011

REASON
The product has a software problem in which previous patient measurement data gets associated with another patient’s image.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on January 14, 2009. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
740 units

DISTRIBUTION
Nationwide and Internationally