BEUDAMED
    FDA Recall Terminated

    VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.

    Recall: Z-1083-2013 · Initiated January 23, 2012

    Recall

    Recall Number
    Z-1083-2013
    Event Number
    64759
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 23, 2012
    Posted
    April 10, 2013
    Terminated
    February 4, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.

    Reason

    GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may impact Operator or Patient safety.

    Action

    GE Healthcare sent and "Urgent Medical Device Correction" letter dated January 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details and Product Correction. For questions contact your local GE Healthcare Service Represenative.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: AR, CA, GA, IL, IN,IA,LA, MA, MN, MT, NY, OH, PA, TX, VA and the countries of BELGIUM, BURKINA FASO, BRAZIL, CHINA, CANADA, SWITZERLAND, CHILE, COLOMBIA, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, EGYPT, SPAIN, FRANCE, UNITED KINGDOM, CHANA, GUADELOUPE, GREECE, GUYANA, HONG KONG, CROATIA, HUNGARY, INDONESIA, ISRAEL, ITALY, KUWAIT, LEBANON LUXEMBURG, LIBYAN, MOROCCO, MARTINIQUE, MEXICO, NETHERLANDS, NORWAY, PANAMA, PERU, POLAND, PORTUGAL , REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SWEDEN, SINGAPORE, SLOVENIA, SLOVAKIA, SIERRA LEONE, THAILAND, TUNISIA, TURKEY, VENEZUELA, MACEDONIA, PALESTINE, SOUTH AFRICA.

    Quantity

    1296