FDA-Device2015-02-18Class II
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.
Siemens Medical Solutions USA, Inc.
Hazard
There is a low probability the scanner arm will become completely detached from the scanner column.
Sold states
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.
Affected count
24 units
Manufactured in
685 E Middlefield Rd, N/A, Mountain View, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2015Don't want to check this manually?
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