FDA Device recall Z-0930-2013
ACUSON S2000 Automated Breast Volume Scanner (ABVS)
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of ACUSON S2000 Automated Breast Volume Scanner (ABVS) by Siemens Medical Solutions Usa, citing on some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0930-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-18 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | OH, WV |
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
On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
Identifiers
| code_info | Model number 10042541 - AVBS module. Note: the S2000 system part number is 10041461, however only those systems tha…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2013%22
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