BEUDAMED
    FDA Recall Terminated

    ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.

    Recall: Z-0182-2016 · Initiated October 7, 2015

    Recall

    Recall Number
    Z-0182-2016
    Event Number
    72372
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 7, 2015
    Posted
    October 30, 2015
    Terminated
    October 19, 2017
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.

    Reason

    Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected.

    Action

    On August 19, 2015, Siemens Ultrasound began sending a customer notification to users, advising them to correct the uppercase/lowercase differences in the patient name at the time of registration until the issue is resolved with a future software release. Siemens believed that the other issues in this correction will begin approximately November 30, 2015 and December 31, 2015. Field service reps will visit sites to install software updates or hardware corrections.

    Distribution

    Worldwide Distribution -- US and Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mexico, Netherlands, New Zealand, Nigeria, Norway, P.R. China, Pakistan, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

    Quantity

    2,099 units