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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi

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 Class 2 Device Recall Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi see related information
Date Posted May 01, 2013
Recall Status1 Terminated on November 03, 2014
Recall Number Z-1207-2013
Recall Event ID 64918
510(K)Number K081028  K083147  K091536  K052293 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant.

Indicated for use as a diagnostic imaging device.
Code Information 0470MR0
00000260626MR7
00000260698MR6
00000260699MR4
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00000261068MR1
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00000261877MR5
00000261879MR1
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00000262150MR6
00000262151MR4
00000262458MR3
00000262464MR1
00000262735MR4
00000262908MR7
00000262933MR5
00000262935MR0
00000263313MR9
00000263507MR6
00000263686MR8
00000263792MR4
00000263832MR8
00000263972MR2
00000264529MR9
00000264617MR2
00000265062MR0
00000265066MR1
00000265183MR4
00000009604YR0
00000265718MR7
00000265720MR3
00000265824MR3
00000265827MR6
00000009847YR5
00000265964MR7
00000010393YR7
00000266129MR6
00000010527YR0
00000266460MR5
00000266754MR1
00000266799MR6
00000266825MR9
00000266828MR3
00000267180MR8
00000267324MR2
00000268049MR4
00000268283MR9
00000268471MR0
00000268524MR6
00000010531YR2
00000269045MR1
00000269047MR7
00000269214MR0
00000269336MR4
00000269340MR6
00000269380MR2
00000270386MR6
00000270462MR5
00000270976MR4
00000271051MR5
00000271561MR3
00000010533YR8
00000271753MR6
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00000272284MR1
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00000272896MR2
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00000273632MR0
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00000010601YR3
00000274745MR9
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00000275583MR3
00000275647MR6
00000275648MR4
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00000275961MR1
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00000276043MR7
00000276245MR8
00000276266MR4
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00000281937MR3
00000282371MR4
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00000282547MR9
00000282788MR9
00000282794MR7
00000282817MR6
00000282868MR9
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00000283075MR0
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00000283346MR5
00000283377MR0
00000011009YR8
00000283408MR3
00000283664MR1
00000283682MR3
00000283815MR9
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00000283865MR4
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00000284025MR4
00000284034MR6
00000011061YR9
00000284235MR9
00000284263MR1
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00000284389MR4
00000284391MR0
00000284407MR4
00000284409MR0
00000284466MR0
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00000284490MR0
00000284563MR4
00000284576MR6
00000284599MR8
00000284640MR0
00000284709MR3
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00000284838MR0
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00000011123YR7
00000285055MR0
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00000286743MR0
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00000286785MR1
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00000286851MR1
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00000286886MR7
00000286982MR4
00000287026MR9
00000287078MR0
00000287081MR4
00000287391MR7
00000287442MR8
00000287626MR6
00000287628MR2
00000287649MR7
00000287767MR8
00000287770MR2
00000287826MR2
00000287846MR0
00000287864MR3
00000287940MR1
00000288015MR1
00000011711YR9
00000288096MR1
00000288097MR9
00000288192MR8
00000288383MR3
00000288651MR3
00000288690MR1
00000288702MR4
00000011873YR7
00000011877YR8
0000028
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
FDA Determined
Cause 2
Software design
Action GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.
Quantity in Commerce 4338
Distribution Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.
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, LLC
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