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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 Posted September 18, 2013
Recall Status1 Terminated 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
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0000AH11228004
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00000Z11216001
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00000L3AAECB80
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0000AL11138004
00000G11270001
0000AP11266001
0000AK11081004
00000Q11076012
00000Q11076010
00000Q11076013
00000Y11243001
00000Y11243004
00000N11137004
00000S11213007
0000AD11199002
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0000AL11138001
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0000AR11306002
00000Y11243009
0000AP11301002
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0000AH11228002
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0000AA12016001
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0000AE11311022
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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 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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