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U.S. Department of Health and Human Services

Class 2 Device Recall VMX, VMX Plus

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 Class 2 Recall
VMX, VMX Plus
see related information
Date Posted April 10, 2013
Recall Status1 Terminated on February 04, 2014
Recall Number Z-1083-2013
Recall Event ID 64759
Premarket Notification
510(K) Number
K910902 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product 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.
Code Information 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 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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 1296
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = GE MEDICAL SYSTEMS
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