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.
Reported: February 18, 2015 Initiated: January 12, 2015 #Z-1063-2015
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.
Reason for Recall
There is a low probability the scanner arm will become completely detached from the scanner column.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 24 units
- Distribution
- 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.
- Location
- Mountain View, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 24 units.
Why was this product recalled? ▼
There is a low probability the scanner arm will become completely detached from the scanner column.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1063-2015.
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