ACUSON S2000

General purpose ultrasound diagnostic imaging equipment

Model: Catalogue numbers – 10041461, 10440017 and 10441730, Affected: , Software version: Version VC25

Model: 10441701, 10041461, 10440017, 10441730, Affected: , Software version: VC30A, VC30B, VC30C, or VC31A

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Serial numbers 250157-250190.

Radiology Devices

2

No

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.

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.