Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 6/8/2011
Class ll:
PRODUCT
ACUSON S2000 ultrasound system. Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications. Model Number 10041461-ACUSON S2000. Recall # Z-2051-2011
REASON
The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report..
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on March 15, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1533 units
DISTRIBUTION
Nationwide and Internationally
