Z-0930-2013Class II

ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical...

Name: Z-0930-2013 ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2013-01-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-01-18 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The... on 2013-01-18. FDA classified it as Class II and gives the reason as "On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0930-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-18
Posted: 2013-03-09
Terminated: 2013-07-16
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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0930-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0930-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-09

Product code IYO

K081148Class IISiemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI / cleared 2008-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)