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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 Device 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
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 6782MO64CS
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00000001913YY3
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00000106837MO8
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00000085137YY8
00000022986YY4
00106782MO58CS
00000022995YY5
00106782MO59CS
00000024586YY0
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00000106820MO4
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00000106835MO2
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00000106751MO1
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00000118271MO6
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00106782MO56CS
00000147664MO7
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00059632YY97CS
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00106782MO43CS
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00000010930YY6
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00059632YY78CS
00000022994YY8
0000
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
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
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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