ACUSON S2000 Automated Breast Volume Scanner — Class II medical device recall Z-0930-2013
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2013-03-20, distributed in OH, WV. On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
| Recall number | Z-0930-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Mountain View, CA, United States |
| Recall initiated | 2013-01-18 |
| Classified | 2013-03-09 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-07-16 |
| Distributed | OH, WV |
| Countries outside the US | AT, AU, BE, BH, BR, CN, DE, EE, FR, GB, GR, ID, IL, IN, IT, JO, JP, KR, KW, LB, MX, MY, NL, PE, PH, PL, PT, QA, RO, SE, TH, TR, TW, VE |
| Quantity | 214 affected |
| Model numbers | 10041461, 10042541 |
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.
Reason for recall
On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0930-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.