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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Advantage Workstation, READY View Application

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 Class 2 Recall
GE Healthcare, Advantage Workstation, READY View Application
see related information
Date Posted September 18, 2013
Recall Status1 Open
Recall Number Z-2241-2013
Recall Event ID 66111
Premarket Notification
510(K) Number
K110573 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Code Information Mfg Lot or Serial # 00000235940GE4 00000260698GE6 00000260686GE1 00000235943GE8 00000253548GE2 00000260699GE4 000000010006GS 00000L3AB501ED 00000253550GE8 00000253551GE6 00000260681GE2 00000260682GE0 00000260683GE8 00000260684GE6 00000260685GE3 00000260687GE9 00000260688GE7 00000260689GE5 00000260690GE3 00000260691GE1 00000260692GE9 00000260693GE7 00000260694GE5 00000260695GE2 00000260696GE0 00000260697GE8 00000253549GE0 00000235942GE0 0000AQ11258001 000000010005GS 0000CZC1337NYP 00000Q11076015 0000AV11249006 0000AQ11265005 0000AQ11265003 000D1L3AAF7CD2 00000L3AB68D60 00000L3A2BABE7 00000L3AAFB343 00000235941GE2 000000010022GS 00000222344GE4 00000253546GE6 000000010013GS 00000L6B045EFC 000000010012GS 00000L3A330899 00000LFB4460DC 0000AJ11175002 0000AJ11175001 00000E11248004 00000E11248003 00000W11292005 00000W11292006 00000W11292007 00000W11292008 0000AC11273001 0000AC11273002 0000AA11187002 0000AA11187003 0000AA11187004 0000AQ11258003 0000AP11140002 0000AP11140001 0000AH11150002 00000Q11076020 0000AV11249001 00000X11194003 00000X11194002 00000X11194004 00000X11194005 00000B11174002 00000B11174001 0000AJ11286002 00000J11284003 00000J11284002 00000J11284001 00000J11284005 00000J11284006 0000AU11262001 0000AU11262002 00000H11164001 00000Q11076024 00000Q11076025 000000010001GS 00000E11248008 0000AY11264001 0000AQ11265008 00000Q11076016 0000AK11167001 0000AK11167002 00000Q11076017 00000S11083002 00000K11087001 0000AK11125001 000000010002GS 00000Z11126002 00000W11189006 0000AD11199001 0000BC11167004 0000BC11167003 0000AH11228004 0000AF11256001 00000E11248002 00000W11178001 0000AF11181001 0000AF11181002 0000AA11187005 0000AA11187006 00000Y11243005 0000AP11266003 0000AQ11265002 0000AQ11265001 00000Z11299002 00000W11292001 00000W11189004 00000Z11216001 00000Z11216002 00000S11213006 0000AH11228003 00000L3AAECB80 0000BA11200003 0000BA11200004 0000AL11138004 00000G11270001 0000AP11266001 0000AK11081004 00000Q11076012 00000Q11076010 00000Q11076013 00000Y11243001 00000Y11243004 00000N11137004 00000S11213007 0000AD11199002 0000AD11199003 0000AL11138001 0000AL11138002 0000AL11138003 0000AR11306002 00000Y11243009 0000AP11301002 0000AR11306003 00000S11312001 00000S11312003 00000S11312004 0000AH11228002 0000AQ11265006 0000AQ11265007 00000Y11243007 00000Y11243008 0000AA12016001 0000AR11306001 0000AE11311002 0000AE11311021 0000AE11311019 0000AE11311020 0000AE11311003 0000AE11311018 0000AE11311022 0000AE11311023 0000AE11311014 0000AE11311015 0000AE11311016 0000AP12033001 0000AE12026003 0000AE12026005 00000Y12030002 00000L3A6D0941 00000L3AADF4FB 00000LE4F3757E 000000010034GS 00000L3F935D18 00000L3AA81D41 00000L02687621 00000L3AB1FBBF 000000010049GS 000000010053GS 000000010054GS 000000010039GS 000000010040GS 000000010042GS 0000CZC1315TNX 00000J11284007 0000AU11262006 00000Y11243002 00000Y11243003 0000AP11140003 00000Z11280005 0000AM12002002 0000AA11363001 000000010043GS 000000010038GS 00000L3A996740 00000LB8CDB080 00000L3A6D207A 00000L3AA6F78A 00000L3AA6F789 00000L02547408 00000L3AB68E25 00000X11194001 00000S11213002 0000AM12002003 000000010032GS 0000AM12002001 00000Q11076021 0000AB11356001 00000L3AB69372 00000N12013001 00000S11083001 00000S11312008 00000LFB4BFCC8 00000L8B31E2E6 00000L3AAF7CEF 0000AO11236001 00000K11201001 00000U12011004 00000S11213004 0000AJ11286001 00000S11213003 0000AE11311012 0000AQ11265004 0000AR11306005 0000AQ11258002 0000AE11242004 00000U12011001 00000R12020001 00000R12020002 00000R12020003 00000R12019002 00000S11312006 0000AA11363004 00000U12011003 00000R12009001 00000R12019003 00000U12011002 00000L3AA6F797 00000K11201004 00000S11312005 0000AU11262007 0000AU11262008 0000AE11311004 00000U11346001 00000K11090001 0000AP11266002 0000AE11311011 0000AA11363006 0000AX11124001 0000BA11200001 0000BA11200002 00000Z11299004 00000T11291001 00000Q11342001 0000AP11116001 0000BC11167001 000000010047GS 0000AE11242001 00000L3AAEC8F5 00000L3AB2DBBA 000000010029GS 00000L3AAEC8A9 00000L3AA81CE5 000000010045GS 00000L3AB68EE4 000000010044GS 00000E11248007 0000CZC1456R18 00000L3AB2DF9E 00000L3AB04721 00000L3A77E646 00000Z11280001 0000AK11081001 0000AA11187001 00000V11361001 00000V11361002 00000V11361003 00000X12023001 00000206069HP7 000000010051GS 0000BC11167005 00000S11312002 0000AV11249004 0000AV11249005 00000Q11342002 00000L3AB68EFF 00000L3AB7CC7C 0000BH11122001 0000BH11122003 00000Z11280002 0000AE12026002 00000S11312009 00000S11312010 00000L3AB7CC6E 00000Q11076005 00000Q11076006 00000Q11076001 00000Q11076002 00000Q11076003 00000Q11076004 0000AK11081003 0000AF11256002 0000AF11256003 00000Y12030001 0000AD11350002 00000L3AB04510 00000L3AB68F20 00000LE23E906A 000000010048GS 0000AA11363003 000000010041GS 00000L3AB677C5 00000L3A99855B 00000L3AB68DA1 0000AE11242005 0000AE11242006 00000Q11076009 00000L3AB68D48 00000Y11104001
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE provided Urgent Medical Device Correction letters to consignees in the following countries: Canada, Finland, France, Germany, Guadeloupe, Italy, Japan, Latvia, Martinique, Netherlands, Norway, Poland, Reunion, Romania, Saudi Arabia, Singapore, Spain,Sweden, Switzerland, Turkey and the United Kingdom. The letters were dated March 27, 2012 and were addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US 800-437-1171, Japan 0120-055-919 and for other countries contact your local GE Healthcare Service Representative). *Letters to other consignees is being planned for September 2013.
Quantity in Commerce 318 (28 USm 290 OUS)
Distribution Worldwide Distribution-USA including the states of IL, MN, NJ, NY, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GUADELOUPE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN,KOREA, LATVIA, MARTINIQUE, NETHERLANDS, NORWAY, PHILIPPINES,S POLAND, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VIETNAM.
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 = LLZ and Original Applicant = GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
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