BEUDAMED
    FDA Enforcement Class II Terminated

    GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).

    Recall: Z-2986-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2986-2018
    Event ID
    80928
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2018
    Initiation Date
    March 22, 2018
    Classification Date
    September 6, 2018
    Termination Date
    August 24, 2021
    Address
    9900 W Innovation Dr, N/A, Milwaukee, WI, 53226-4856, United States

    Description

    GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).

    Reason

    The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

    Code Info

    Each consignee have one serial numbers assigned

    Distribution

    Nationwide and Puerto Rico FOREIGN: Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Brazil, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Congo, The Democratic Republic of the Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam

    Quantity

    12,426 (4,717 US; 7,709 OUS ALL PRODUCTS)