ACUSON S2000 Automated Breast Volume Scanner — Class II medical device recall Z-1063-2015
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-02-18, distributed in MN, TX. There is a low probability the scanner arm will become completely detached from the scanner column.
| Recall number | Z-1063-2015 |
|---|---|
| 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 | 2015-01-12 |
| Classified | 2015-02-07 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-06-10 |
| Distributed | MN, TX |
| Countries outside the US | CN, DE, FR, IT, SA, TH, TW |
| Quantity | 24 units |
| Reason classes | device malfunction |
| Serial numbers | 250157-250190 |
| Model numbers | 10434730 |
Product
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
Reason for recall
There is a low probability the scanner arm will become completely detached from the scanner column.
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-1063-2015. 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.