FDAFDA · Food and drugs·Recall number Z-1083-2013
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.
Published April 17, 2013 · Recall initiated: January 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- FMI 10850: VMX ARM BASE CASTING REPLACEMENT Serial Number 00000155075MO5 00000006136YY6 00000006802YY3 00000006799YY1 00000007989YY7 00000007990YY5 00000002358YY0 00000021131YY8 00000021132YY6 00000021146YY6 00000021139YY1 00000021141YY7 00000021159YY9 00000041750YY1 00000021108YY6 00000041725YY3 00000041778YY2 00000083296YY4 00000085032YY1 00000118252MO6 00000085956YY1 00000160478MO4 00000021116YY9 00000021017YY9 00000011088YY2 00000024550YY6 00000021097YY1 00000031512YY7 00000031585YY3 00000025793YY1 00000002355YY6 00000006148YY1 00000147625MO8 00000021024YY5 00000021134YY2 00000021140YY9 00000024543YY1 00000021103YY7 00000021107YY8 00000021151YY6 00000041762YY6 00000041772YY5 00000041768YY3 00000041766YY7 00000041764YY2 00000041771YY7 00000041770YY9 00000041784YY0 00000041783YY2 00000083295YY6 00000140455MO7 00000140451MO6 00000086024YY7 00000086043YY7 00000086036YY1 00000086025YY4 00000086046YY0 00000086048YY6 00000140453MO2 00000086049YY4 00000086032YY0 00000086026YY2 00000086033YY8 00000140467MO2 00000140473MO0 00000140459MO9 00000140464MO9 00000140460MO7 00000140471MO4 00000160470MO1 00000008077YY0 00000083292YY3 00000059632YY1 00000006796YY7 00000006804YY9 00000021157YY3 00000021158YY1 00000041780YY8 00000086001YY5 00000086016YY3 00000086017YY1 00000140487MO0 00000021051YY8 00000155065MO6 00000085037YY0 00000085031YY3 00000084999YY2 00000106771MO9 00059632YY70CS 00000140535MO6 00059632YY71CS 00000005327YY2 00000013802YY4 00000024542YY3 00000024564YY7 00000031588YY7 00000048207YY5 00000048221YY6 00000048220YY8 00000059601YY5 00000083261YY8 00000085043YY8 00000085060YY2 00000085081YY8 00000085080YY0 00000089505MO2 00106782MO35CS 00000089509MO4 00000089520MO1 00000089522MO7 00000089532MO6 00106782MO37CS 00000089547MO4 00000106753MO7 00000118276MO5 00000118277MO3 00000118279MO9 00000118278MO1 00000140525MO7 00059632YY72CS 00000140526MO5 00000140546MO3 00000147624MO1 00000106778MO4 00000106780MO0 00000155024MO3 00000041752YY7 00000025765YY9 00000059632YY3 00000048275YY2 00000106782MO8 00000106769MO3 00000155057MO3 00000010905YY8 00000011006YY4 00000013795YY0 00000140503MO4 00000140510MO9 00000147655MO5 00000155022MO7 00000008195YY0 00000011112YY0 00000021000YY5 00000008116YY6 00000008117YY4 00000011046YY0 00000023060YY7 00000086021YY3 00000005259YY7 00000006765YY2 00000022983YY1 00000022996YY3 00000010898YY5 00000002303YY6 00000005295YY1 00000005260YY5 00000011047YY8 00000002322YY6 00000010942YY1 00000023020YY1 00106782MO54CS 00000010952YY0 00000022997YY1 00000024574YY6 00000013817YY2 00000011017YY1 0059632YY123CS 00000085020YY6 00000005239YY9 00000005267YY0 0059632YY103CS 00059632YY94CS 00000085030YY5 00000011019YY7 00000008003YY6 00000005243YY1 00000022982YY3 00000014353YY7 00000021098YY9 00000007963YY2 00000023061YY5 00000007957YY4 00000007956YY6 00000023037YY5 0059632YY105CS 00000021063YY3 00000021092YY2 00000021091YY4 00000002349YY9 00000002330YY9 00000002329YY1 00000008133YY1 00000008132YY3 00000021088YY0 00000002317YY6 00000002318YY4 00000006791YY8 00000006793YY4 00000011070YY0 00000006779YY3 00000008141YY4 00000002340YY8 00000002282YY2 00000008196YY8 00000005250YY6 00000005352YY0 00000008200YY8 00000008199YY2 00000008001YY0 00000013816YY4 00000086022YY1 00000005287YY8 00000036034YY6 00000005324YY9 00000005253YY0 00000005254YY8 00000011102YY1 00000001904YY2 00000083284YY0 00000002308YY5 00000024553YY0 00000010956YY1 00000024577YY9 00000024582YY9 00000013805YY7 00000010993YY4 00000024555YY5 00000011122YY9 00000008185YY1 00000008184YY4 00000085958YY7 00000002288YY9 00000008013YY5 00000013814YY9 00000013808YY1 00000021023YY7 00000005315YY7 00000022985YY6 00000023039YY1 00000021052YY6 00000023055YY7 00000005310YY8 00000005309YY0 00000010979YY3 00000021012YY0 00000021013YY8 0010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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