BEUDAMED
    FDA Recall Terminated

    GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems

    Recall: Z-0541-2010 · Initiated October 22, 2009

    Recall

    Recall Number
    Z-0541-2010
    Event Number
    53519
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 22, 2009
    Posted
    December 16, 2009
    Terminated
    December 17, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems

    Reason

    GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that may impact patient safety. When using the combination of 2D-CRI and PW with a steered Doppler angle, the displayed velocity scale is incorrect. The consequence can be an underestimation of flow v

    Action

    Consignees were sent on 10/23/09 a GE healthcare "Urgent Medical Device Correction" letter dated 10/22/09. The letter was addressed to Hospital Administration/Risk manger, Primary Physician and Biomedical Dept. Manger. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Questions and concerns regarding this issue are directed to the local GE Healthcare service representative or to 1-800-437-1171. GE also plans to update all of the affected GE Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems that were distributed.

    Distribution

    AL, AR, CA, CT, FL, GA, IL, KS, KY, LA ME, MD, MA, MI, MN,MS, MO, NE NJ, NY, NC, OH, OK PA, SC, TN,TX, VA,WI. AUSTRALIA, AUSTRIA , BELGIUM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ITALY, JAMAICA, JAPAN, KOREA, KUWAIT, LITHUANIA, MALAYSIA. NETHERLANDS, NE ZEALAND, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, UNITED ARAB, EMIRATES, UNITED KINGDOM, MEXICO, VENEZUELA.

    Quantity

    715