BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1063-2015 · Initiated January 12, 2015

    Recall

    Recall Number
    Z-1063-2015
    Event Number
    70361
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    January 12, 2015
    Posted
    February 7, 2015
    Terminated
    June 10, 2015
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    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

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

    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.

    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.

    Quantity

    24 units