BEUDAMED
    FDA Recall Terminated

    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.

    Recall: Z-1584-2015 · Initiated July 11, 2012

    Recall

    Recall Number
    Z-1584-2015
    Event Number
    71122
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 11, 2012
    Posted
    May 6, 2015
    Terminated
    May 6, 2015
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.

    Reason

    In certain situations, loss of post exercise images can occur in Stress Echo.

    Action

    On 07/11/2012 a field corrective action was initiated via update programs US016/12/P to update all affected SC2000 customers to software version VA20C, which contains the fix to the described issue. Each customer received a site visit to install the software update.

    Distribution

    Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, and Venezuela.

    Quantity

    476