Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0930-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 18, 2013

Date Posted: March 20, 2013

Recall Number: Z-0930-2013

Event ID: 64231

Reason for Recall:

On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.

Status: Terminated

Product Quantity: 214 affected devices

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated