CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report

Acuson S2000 Automated Breast Volume Scanner (Abvs) recalled

Siemens Medical Solutions USA is recalling Acuson S2000 Automated Breast Volume Scanner (Abvs), distributed in Ohio, West Virginia. The recall was initiated on 18 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled214 affected devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0930-2013
FDA event ID: 64231
Recalling firm: Siemens Medical Solutions USA, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 18 Jan 2013
FDA classified: 9 Mar 2013
Reported: 20 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

18 Jan 2013	Recall initiated by company
9 Mar 2013	Classified by FDA	+50 days
20 Mar 2013	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Ohio West Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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