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