FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: 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.
- Recall number
- Z-0930-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-01-18
- Posted
- 2013-03-09
- Terminated
- 2013-07-16
- Reason
- On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
- Root cause
- Process design
- Action
- Siemens sent a Customer Safety Advisory notification letter to Siemens Service Personnel on January 18, 2013 and which would be provided to all affected sites during their visit to correct the problem. The notification identified the product, the problem and the action to be taken. The local Customer Service Engineer will perform the test at their site. If the system passes the test, no further action is required. If the ABVS pod fails the inspection, the Service Engineer will correct the sharp edge. For questions regarding this recall call 650-694-5398.
- Quantity
- 214 affected devices
- Distribution
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K081148"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28