BEUDAMED
    FDA Recall Terminated

    GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal, thoracic, vascular and neurological).

    Recall: Z-0834-2012 · Initiated December 23, 2011

    Recall

    Recall Number
    Z-0834-2012
    Event Number
    60781
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 23, 2011
    Posted
    January 21, 2012
    Terminated
    January 21, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal, thoracic, vascular and neurological).

    Reason

    GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators.

    Action

    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. Contact the GE Support Center at 1-800-321-7937 or your local GE Healthcare service representative for questions regarding this issue.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KY, LA, ME, MA, MI, MN, MS, MO, MT, NE, NV, NH, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, and WI. and countries of VENEZUELA, UNITED KINGDOM TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARAIA, RUSSIAN FEDERATION, ROMANIA, REPUBLIC OF KOREA, QATAR, PROTUGAL, POLAND, PHILIPPINES, PERU, OMAN, NORWAY, MEXICO, MALAYSIA, LITHUANIA, LEBANON, KOSOVO, KENYA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ONDONESIA, INDIA, HUNGRY, HONG KONG, GUATEMALA, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, and ALGERIA.

    Quantity

    2270