Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/13/2011
Class ll:
PRODUCT
Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician…for clinical diagnosis purposes. Recall # Z-1832-2011
REASON
The images captured from the device may be erroneous.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on February 16, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,903 units
DISTRIBUTION
Nationwide and Internationally