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.
FDA Recall Z-1063-2015 · Posted 2015-02-07
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2015-01-12
Date Terminated2015-06-10
Product Quantity24 units
Reason for Recall
There is a low probability the scanner arm will become completely detached from the scanner column.
Firm Action
Siemens sent a Customer Safety Advisory Notification to all affected sites on January 12, 2015, certified mail, with return receipt. The letter identified the affected product, the issue, and potential risk. Customers were asked to immediately discontinue use of the affected product. A Customer Service Engineer will contact customers to schedule an appointment to make the necessary repairs. Questions should be directed to a local service support person for information regarding timelines and status. Customers are to share the information with all personnel, who need to be aware of the issue.
Root Cause
Vendor change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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