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Recall Observatory FDA recall evidence

Device 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.

Z-1063-2015

January 12, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 70361
Status
Terminated
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-1063-2015

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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