FDAJanuary 12, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a low probability the scanner arm will become completely detached from the scanner column.
What to do
FDA enforcement status: Terminated
Brands named
siemens medical solutionssiemenssiemens medical
UPCs
250157250190
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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