FDA Device recall Z-1063-2015
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730 by Siemens Medical Solutions Usa, citing there is a low probability the scanner arm will become completely detached from the scanner column.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1063-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-12 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | MN, TX |
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
There is a low probability the scanner arm will become completely detached from the scanner column.
Identifiers
| code_info | Serial numbers 250157-250190. |
|---|
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-1063-2015%22
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