BEUDAMED
    FDA Recall Terminated

    GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).

    Recall: Z-0588-2019 · Initiated September 14, 2018

    Recall

    Recall Number
    Z-0588-2019
    Event Number
    81165
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 14, 2018
    Terminated
    May 29, 2019
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).

    Reason

    There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.

    Action

    The recalling firm, GE Healthcare, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 9/14/2018 via traceable means to each of their customer locations. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Do not use a TEE probe (GE model 6Tc-RS) from another device on the LOGIQ E10 system until your LOGIQ E10 is corrected. You may scan normally with any other probes. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AZ, IL, MA, ME, MN, MT, PA, TX, and WA and countries of: Foreign distribution was made to Austria, Denmark, Finland, and Norway.

    Quantity

    103 devices(64 US; 39 OUS)