BEUDAMED
    FDA Enforcement Class II Ongoing

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    Recall: Z-2350-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2350-2019
    Event ID
    83398
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    January 28, 2019
    Classification Date
    August 22, 2019
    Address
    685 E Middlefield Rd, N/A, Mountain View, CA, 94043-4045, United States

    Description

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    Reason

    The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware

    Code Info

    All product lots of the Acuson NX2, model # 11284381 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL,IA, IN, KY, LA, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY; and countries of: Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Philippines, Poland, Portugal, Republic of Korea, Romania, Ruanda, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, U.A.E., Uganda, Ukraine, United Kingdom, Uruguay, Uzbekistan and Vietnam.

    Quantity

    1869 systems