Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1063-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 12, 2015

Date Posted: February 18, 2015

Recall Number: Z-1063-2015

Event ID: 70361

Reason for Recall:

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

Status: Terminated

Product Quantity: 24 units

Code Information:

Serial numbers 250157-250190.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated