BEUDAMED
    FDA Recall Terminated

    Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.

    Recall: Z-1900-2011 · Initiated January 14, 2009

    Recall

    Recall Number
    Z-1900-2011
    Event Number
    51497
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    January 14, 2009
    Posted
    April 6, 2011
    Terminated
    April 6, 2011
    Address
    1230 Shorebird Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.

    Reason

    The product has a software problem in which previous patient measurement data gets associated with another patient's image.

    Action

    The firm, SIEMENS, issued a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that the first image in Exam Review is from the current patient; ensure that the Heart Cycle measurement tool is not selected on the Cale menu when entering Exam Review; be aware of this issue as described in the letter and perform four (4) or less measurements of the same measurement label. Should you have any questions, please call (650) 694-5398.

    Distribution

    Worldwide distribution.