[Recalled] 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 v
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Siemens Medical Solutions USA, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1063-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 January 2015 |
| EAN / barcode | 10434730 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a low probability the scanner arm will become completely detached from the scanner column.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.