BEUDAMED
    FDA Recall Terminated

    ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.

    Recall: Z-1616-2012 · Initiated April 25, 2012

    Recall

    Recall Number
    Z-1616-2012
    Event Number
    61803
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 25, 2012
    Posted
    May 16, 2012
    Terminated
    October 19, 2012
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.

    Reason

    When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.

    Action

    A field corrective action was initiated on 04/25/2012 under Siemens update program US019/12/S in which a "Customer Safety Advisory Notice" was sent to all customers notifying them of the problem and the recommended actions to avoid potential risk. A follow-up field corrective action will be initiated in which the affected software will be updated in the field.

    Distribution

    Worldwide Distribution -- USA, including the states of TX, NJ, GA and the countries of Germany, United Kingdom, Republic of Korea, Australia, Japan, Poland, Israel, Singapore, France and Saudi Arabia.

    Quantity

    45