Siemens Medical Solutions USA, Inc. recalls ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 -

Recalled February 18, 2015 · FDA recall Z-1063-2015 · Siemens Medical Solutions USA

Hazard

There is a low probability the scanner arm will become completely detached from the scanner column. · FDA Class II

Units

24 units

Sold at

Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy.

Description

There is a low probability the scanner arm will become completely detached from the scanner column.

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.

Manufacturer(s)

Siemens Medical Solutions USA, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →