Device Recall ACUSON S2000 Automated Breast Volume Scanner (ABVS);

Model number 10042541 - AVBS module.  Note: the S2000 system part number is 10041461, however only those systems that include the ABVS module, part number 10042541 are affected. Manufactured prior to 10/30/2012.

Radiology Devices

2

No

Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Qatar, Rep of Korea, Romania, Sweden, Taiwan, Thailand, Turkey, Unite Arab Emirates, United Kingdom and Venezuela.

ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 || Distributed by Siemens Medical Solutions USA Inc. || business Unit: Ultrasound. || The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.