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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 Device Recall GE Healthcare, Advantage Workstation, READY View Application see related information
Date Initiated by Firm March 27, 2012
Date Posting Updated September 18, 2013
Recall Status1 Terminated 3 on November 21, 2014
Recall Number Z-2241-2013
Recall Event ID 66111
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, 0000BA1120
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 that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
FDA Determined
Cause 2
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 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 = LLZ and Original Applicant = GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
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