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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery MR750w /MR750, Optima MR450w, Discovery MR450, 1.5/3T Signa HDxt, Signa Vibrant.

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 Class 2 Recall
Discovery MR750w /MR750, Optima MR450w, Discovery MR450, 1.5/3T Signa HDxt, Signa Vibrant.
see related information
Date Posted September 23, 2013
Recall Status1 Open
Recall Number Z-2266-2013
Recall Event ID 65992
Premarket Notification
510(K) Numbers
K081028  K083147  K103327  K113490  K121676 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit
FDA Determined
Cause 2
DESIGN: Software Design
Action Customers were sent two GE Healthcare "Urgent Medical Device Correction" letters one dated April 9, 2013, and the other May 22, 2013, each addressing one of the 2 groups of MR Products involved in the recall. The letters were addressed to Hospital Administrators / Risk managers, Radiology Department Mangers and Radiologists. The letters described the Safety Issue and provided Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected systems by providing a software update at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. Contact your local service representative if you have any questions concerning this notification. For further questions please call (262) 513-4122.
Quantity in Commerce 1,246 (521 US and 725 OUS)
Distribution Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY.
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 = LNH and Original Applicant = GE HEALTHCARE JAPAN CORPORATION
510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC
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