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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 Initiated by Firm January 23, 2012
Date Posted April 10, 2013
Recall Status1 Terminated 3 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 FMI 10850: VMX ARM BASE CASTING REPLACEMENT Serial 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Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = GE MEDICAL SYSTEMS
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