BEUDAMED
    FDA Recall Terminated

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    Recall: Z-1962-2014 · Initiated June 3, 2014

    Recall

    Recall Number
    Z-1962-2014
    Event Number
    68529
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 3, 2014
    Posted
    July 1, 2014
    Terminated
    May 25, 2016
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    Reason

    There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

    Action

    Siemens sent a Customer Safety Advisory Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: To avoid the potential risk of this issue, do not use the Auto-Stats tool; use alternate measurement tools. Only use the Velocity tool on frozen images. Customer Service Engineer will contact the customer to schedule an appointment to replace their existing version of software, free of charge. Customers with questions should contact their local service support person for information regarding timelines and status. Customers were instructed to share this information with all personnel within their organization who need to be aware of this issue. For questions regarding this recall call 650-694-5135.

    Distribution

    Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.

    Quantity

    790 units