BEUDAMED
    FDA Recall Terminated

    GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a qualified physician for ultrasound evaluation of Fetal?OB; abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal , PV neurological).

    Recall: Z-2404-2008 · Initiated April 1, 2008

    Recall

    Recall Number
    Z-2404-2008
    Event Number
    49068
    Firm
    GE Healthcare
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 1, 2008
    Posted
    September 22, 2008
    Terminated
    December 11, 2011

    Description

    GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a qualified physician for ultrasound evaluation of Fetal?OB; abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal , PV neurological).

    Reason

    Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety.

    Action

    Consignees were sent a GE "Urgent Medical device Correction" letter dated April 1, 22008. The letter was addressed to Healthcare Administrator/Risk Manger; Chief of Intensive Care and Director of Clinical Engineering. The letter described the safety issue; affected product details; safety instructions stating that use of the system may be continued and measurements may be made safely in M-Mode by using HD-Zoom rather than pan-Zoom; product correction stating that a GE Healthcare Rep will contact consignees in the future to schedule software updates to resolve the issue at no charge; and contact information.

    Distribution

    Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV,NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT,WA, WI, WV, WY, and PUERTO RICO, and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PARAGUAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.

    Quantity

    1637