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U.S. Department of Health and Human Services

Class 2 Device Recall Signa Excite" 1.5 T Magnetic Resonance Systems, GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

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 Class 2 Recall
Signa Excite" 1.5 T Magnetic Resonance Systems, GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.
see related information
Date Posted November 24, 2010
Recall Status1 Open
Recall Number Z-0462-2011
Recall Event ID 57142
Premarket Notification
510(K) Number
K013636 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Signa® Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Signa¿ MR Excite" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip along the phase encode direction and incorrect annotation, which may result in incorrect localization of anatomy in oblique axial images with the pulse sequences.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 21, 2009. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Field Engineers will contact customers to schedule a field modification of the affected products to address this issue. Customers can contact GE Healthcare at 262 521-6100 about this issue.
Quantity in Commerce 1464
Distribution Worldwide Distribution: Throughout USA except states of AK, VT and WY, and the countries of: Argentina, Australia, Bulgaria, Brazil, China, Canada, Switzerland, Chile, Colombia, Czech Republic, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guatemala, Honduras, Croatia, Hungary, Indonesia, Ireland, India, Iran, Iceland, Italy, Japan, Kenya, South Korea, Kuwait, Lebanon, Luxembourg, Libya, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Puerto Rico, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Syria, Thailand, Tunisia, Turkey, Taiwan, Venezuela, and 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 = LNH and Original Applicant = GE MEDICAL SYSTEMS
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