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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 08, 2016
Create Date July 06, 2016
Recall Status1 Terminated 3 on October 04, 2018
Recall Number Z-2131-2016
Recall Event ID 74442
510(K)Number K142085  K132376  K130115  K103327  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE Healthcare, Discovery MR750w
Code Information  Mfg Lot or Serial # System ID 00001250FMM03D 9075653T 00001308FMM00B 602863MR Missing_SN_GON4205067 480342MR3 00001134FMM10E 928348MR 00001140FMM0FX RADNETMR597 N/A 530CHI750W N/A 858824MR1 00000000UA0083 408356MR1 00001204FMM058 RADNETMR599 00000000UA0262 949760MR3 00000308185MR8 510449MR750W 00000000UA0075 619543HDMR4 00000000UA0118 858622HDMR1 00001204FMM052 415CB3TW 00001309FMM08B RADNETMR613 00001307FMM09Y 415UCBHMR3 1-4G33-86 805739MR3 310871MR9 310264MR2 309905MR8 RADNETMR621 00001204FMM04G 559734VIMR1 000005373011-3 RADNETMR598 N/A 720848MR4 N/A 720848MR3 311108MR5 303492MR 00001118FMM0WE 303604MR2 00001309FMM09E 720854MR 00000000UA0472 719365MR Missing_SN_GON4077136 303837MR2 309815MR9 970624MR1 310950MR1 860446MR750W 00001251FMM00R 202966MR3TW Missing_SN_GON4231312 561955MR1 00001309FMM097 386FNSBMR3T 00001308FMM042 954355MR750W 1309FMM09F 904483MR3T 00000000UA0465 305665MR750W 00001204FMM057 305461MR1 00001140FMM0FG 407SMSLMR1 00001147FMM0E5 386FHPCMR3T 00001223FMM08M 561844MR1 N/A 706787750DV 00001236FMM04Y 912819MR 00001301FMM043 671NAVYMR 00001234FMM0KL 671FHPMR750W 310330MR6 808HRAEMR750W 00001204FMM055 808545MR 00001250FMM035 808YMMR 00000306104MR1 808873MR750W 1-4GFG-928 319335MR2 310776MR0 773665SJMR2 PG75W1600017MR 312702MR750 00001250FMM02E 217876DMH3T N/A 847316MR3T 00000305089MR5 708346MR3 00000307816MR9 708346MR4 310973MR3 309655IMRI 00001309FMM094 309655MR750W N/A 815968MR 00001203FMM0VP 815395MR2 00000306062MR1 847872ZMR2 00000309665MR8 317887MR3 00001308FMM03T 317865MR4 00001308FMM006 913322MISHMRW 310253MR0 859334MR 00001221FMM06J 270798MR2 1406NMM0C2 318443MR2 00000307418MR4 225763MR2 00001236FMM051 337289MR1 1236FMM04H 337943MR1 00001251FMM01F BRIGHAM750WMR1 00001227FMM011 BOSTONMEDMR1 MISSING_SN_GON#4350388 508746MR3 00001250FMM03C VAWESTROX750W 00001309FMM085 410328MR3T 00001204FMM04U RADNETMR1652 00000306342MR7 RADNETMR1651 00001203FMM0W2 RADNETMR1635 00000303329MR7 RADNETMR1629 223355 3014643TMR Missing_SN_GON4216878 240707MR3T 00001301FMM047 301570MR 00000000UA0301 RADNETMR1662 N/A RADNETMR6071 N/A RADNETMR1686 00001308FMM046 207MMC3TMR 130FMM07E 734845VA750MR 1442RG01YE 248533750W 00001227FMM00W 616267IMRI 00001134FMM10U 616774MR750W 00001308FMM01H 763795MR1 00000306613MR1 MR229047 00001250FMM01U MR229046 00001308FMM007 MR229048 UA0368 MR229050 00000000UA0091 314577CGMR3T 00000007T5MV12 336832MR750 00001233FMM06K 6033343TW 00001204FMM04E RADNETMR1631 00001203FMM0UK RADNETMR1632 311106MR9 856537MR N/A 732MSKMR 00001251FMM01C 856581MR3T 00000304496MR3 856247MR3 00001233FMM06X 856247MR1 00001227FMM00T 201445750W 911001 775882GBIMR 00001308FMM02E 702382MR750W 00001309FMM065 702731MR750W 310333MR0 RADNETMR1687 PG75W1600002MR 718854MR 00001134FMM10R 71872MR750W 00000122FMM015 RADNETMR1648 310949MR3 631623MR750 N/A 516NS7113T 00001309FMM07F 914750W 00001203FMM0VB EAST750W PG75W1600021MR MSK68MR03 00001308FMM008 MSK68MR7 00000308347MR4 MSK68MR1 00000000UA0363 MSK53MR02 00001140FMM0FT 21277MR1 N/A 212288MR4 00001236FMM04X COR526967 1406NMM058 716740MR1 00000305184MR4 RADNETMR1639 00001308FMM02T 718226MR3T Missing_SN_GON4292927 914631MR 00000305090MR3 330344MR750W 00001308FMM02C 513636MR4 00001111FMM0B2 61456MR5 309752MR4 614293MR9 00001309FMM09G 6142343T 00001250FMM02H 937641MR2 N/A 937208MR1 00001142FMM08Y 405271OUCMR N/A 405636SMR2 1307FMM088 503251PMR3 1406NMM0C5 412914MR 310902MR2 215829MR750W N/A 215728MR3T 00001308FMM032 PRESBYMR1 00001308FMM028 843815750W 00000306781MR6 843750WGEM 00000306801MR2 864529MR 309780MR5 423493MR750W 00001309FMM047 865984MR750 309948MR8 817433HSWMR2 310952MR7 512544SD3T 00001250FMM02W 214645UT3TMR1 00001308FMM02A 2148203TMR N/A 9157473TMR N/A 409772MR6 00000000UA0396 713792AMR14 00001308FMM05P 713798MR1 PG75W1600019MR 713792AMR16 N/A 903236MR750W PG75W1600011MR 713363MR750 00001251FMM01E 210617HUBMR N/A 210WHASCMR1 00000000UA0304 210AMVAMR 00001134FMM10C 281274MR2 N/A 903525MR750W 00001204FMM04Y 435251MR1 PG75W1500005MR 434MJMR2 PG75W1500001MR 703698MR5 00000000UA0124 703698MR4 00001307FMM089 703573MR1DV 00000304862MR6 757827MR2 00001309FMM0AF 703478MR2DV 00000000UA0141 757983MR N/A 206223VM750W 00001221FMM06M 206292SR750W N/A 206320CH750W 310775MR2 206781SB750W 1307FMM086 920738MR750 00001250FMM02N 608775MR3T 00001251FMM012 608263MR5W 00001309FMM07N 608CHILDMR1 310777MR8 608VAMR750W 00000310697MR8 608265MR750W N/A 414649WB2 00001250FMM03A 414647MR1 00001309FMM05F 715847MR3T Missing_SN_GON4216470 307BHBBJ3T 00000000UA0437 DZ1060MR04 00000310539MR2 DZ1638MR01 00001234FMM0KB MRUA0136 00001309FMM08P MRUA0343 00000309907MR4 83112923995 00000309950MR4 83112923777 00000000UA0226 83096535911 301100984 83092403928 00000308593MR3 83096536248 00000308883MR8 83104203907 00000309051MR1 83096322711 00000309127MR9 83105089955 00000309327MR5 83104653897 00000309453MR9 83108956002 00001134FMM10P 910274040 00001203FMM0VW 910273043 00000309423MR2 AP7645MR01 00001308FMM02N BH1017MR01 00001139FMM0D7 BY4160MR01 00001219FMM0GM 140024MR01 00001233FMM06W 130083MR05 00001308FMM02R 220078MR01 0000310163MR01 220826MR02 00001406NMM0C0 220826MR01 00001309FMM084 441239MR750W 00000000UA0467 MRUA0467 00000309092MR5 MRUA0272 00001309FMM072 MRUA0191 00000310904MR8 MRUA0394A 00001301FMM03E MRUA0122 00001406NMM00K BG4680MR01 663 506648MR4 00000000UA0364 E416249MR2 00001134FMM104 613737MR1 00001437RG01DD 82427040139 00001441RG00L1 82427200086 00001442RG01XE 82427160158 00001437RG01DK 82427160160 00001442RG01XC 82427180035 00000309522MR1 82427160149 00001442RG01Y0 82427170020 00001442RG01XK 82427070157 N/A 82427010087 00001441RG00KT 82427010080 00000305814MR6 82427210118 00001442RG01YT 82427210129 00001438RG00L1 82427210149 00000306638MR8 82427120116 00001406NMM082 82427120122 00000307589MR2 82427120124 00001438RG00L6 82427120159 00001437RG01DM 82427120149 00000307210MR5 82427120110 00001406NMM0BP 82427120136 00000306700MR6 82427040146 00000306350MR0 82427040135 00001442RG01Y9 82427040167 00001308FMM035 82427160127 00001406NMM09V 82427110051 00001406NMM0BE 82427120131 00001309FMM0A8 82427100225 00001406NMM0BJ 82427180028 00001406NMM0B7 82427130076 00001442RG01YR 82427120135 00000309521MR3 82427060052 00000307568MR6 82427100219 00001442RG01Y4 82427100267 00001442RG01YK 82427100254 00001438RG00L3 82427100265 00001442RG01YJ 82427100246 00001438RG00LG 82427140124 00000000UA0482 EG1526MR05 00000310953MR5 A1765918 00001309FMM0A6 M4018549 00001134FMM10K M4166994 00000310538MR4 M4172341 00000311037MR6 M4035023 00000303954MR2 M9481853 00001406NMM0CN M365865301 00001204FMM05C N4192951 00001441RG00JR X41944010 00000309695MR5 M54606125 00000000UA0016 X59007321 00001204FMM048 M2322246 00001204FMM05F M45052106 00001204FMM05J PC9953MR01 00000305145MR5 UC2547MR01 00001236FMM05D HC0220MR03 00001307FMM08H TP4447MR02 00001309FMM04U PC3003MR01 00001117FMMOCN PNUE08MR01 00001117FMM0CP PC9595MR01 0000000UA0332A 409740MR02 00000302668MR9 HC3068MR01 00001140FMM0FF HU1098MR02 00001221FMM06K 8.30278E+13 00000301768MR8 8.30278E+13 00001406NMM05A 8.30272E+13 00000310060MR9 8.30272E+13 00000309164MR2 8.30279E+13 00000309951MR2 8.30279E+13 00001236FMM05Y 8.30272E+13 00000306902MR8 8.30272E+13 00001118FMM0WJ 8.3027E+13 00001250FMM01T 8.3027E+13 00001204FMM054 8.30271E+13 00000311040MR0 8.3027E+13 00001203FMM0V5 835270026 00001308FMM065 IE1010MR01 00000310162MR3 A5547422 00001309FMM05G A5360437 00001301FMM03X A5111746 00001309FMM07R B5174327 00001309FMM0AJ A5719869 00001203FMM0VY B5129925 00001236FMM04P EM0271 00001308FMM05M EM0272 00001308FMM04T EM0229 00001308FMM063 EM0232 00001236FMM00M EM0215 00001234FMM0KA EM0221 00001236FMM01R EM0214 00001309FMM06A EM0245 00001112FMM081 EM0202 00001227FMM00J EM0208 00001250FMM01W EM0227 00001308FMM012 EM0254 00000310839MR6 EM0276 00001236FMM01G EM0213 00001301FMM04H EM0235 00001308FMM05B EM0234 00001406NMM0C7 EM0262 00000310905MR5 EM0269 00000310906MR3 EM0273 00001250FMM02U EM0228 00001236FMM016 EM0238 00000310702MR6 EM0277 00000310474MR2 EM0267 00001308FMM01Y EM0249 00001140FMM0FU EM0205 00001236FMM05E EM0239 00001147FMM0EE EM0222 00001227FMM00C EM0225 00000304861MR8 EM0206 00001221FMM0BB EM0210 00001308FMM03L EM0248 PG75W1500006MR EM0286 00000000UA0488 EM0285 PG75W1500007MR EM0290 00000310677MR0 EM0268 00000310475MR9 EM0264 00000000UA0507 EM0284 PG75W1600006MR EM0289 0000000UA0427A EM0282 00001406NMM080 EM0263 N/A EM0288 00000310588MR9 EM0287 00000310903MR0 EM0274 00000310420MR5 EM0266 00000310720MR8 EM0280 00000310421MR3 EM0281 00001406NMM05U EM0270 00001308FMM034 EM0253 0000000UA0397B EM0283 00001236FMM01H EM0241 00001236FMM020 EM0240 00001308FMM022 EM0244 00001308FMM055 EM0231 00001309FMM09Y EM0257 00001220FMM01J EM0207 00001309FMM051 EM0261 00001308FMM01U EM0265 00001309FMM095 EM0275 00001203FMM0VX EM0219 00001308FMM01P EM0255 00001308FMM020 EM0256 00001203FMMOUW EM0212 00001236FMM05U EM0246 00001234FMM0KH EM0223 00001309FMM08Y EM0243 00001203FMM0V2 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387040MR10 00000310540MR0 259130MR12 00001309FMM05N 150250MR01 00001309FMM06W 725100MR02 00001142FMM092 120810MR02 0000000UA0430A 568987MR01 00000000UA0049 850020MR02 00000310703MR4 123953MR01 00001308FMM048 853270141 00000310604MR4 856270071 00001309FMM07G 06162MRS01 00001227FMM00N 26001MRS01 00001204FMM04B 34348MRS01 00000309908MR2 53008MRS01 00000000UA0097 AE1016MR01 00001142FMM090 10639MRS01 00001309FMM04T 10692MRS01 00001309FMM07M 77266MRS03 00001142FMM094 10678MRS01 00001250FMM038 00010MRS02 00001111FMM0B7 70431MRS04 00000000UA0265 00230MRS01 N/A 00440MRS08 00000310424MR7 10722MRS01 00000310701MR8 20312MRS01 00001406NMM09X MRUA0353                                         
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Consignees were sent on 6/8/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 60901 dated June 8, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 471 (184 US; 287 OUS)
Distribution US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY. OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bermuda Brazil Bulgaria Canada China Egypt France Germany Hungary India Indonesia Ireland Italy Japan Kazakhstan Korea (Republic of) Kuwait Lebanon Mexico Netherlands New Zealand Poland Qatar Romania Russia Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay
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 = LNH and Original Applicant = GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
510(K)s with Product Code = LNH and Original Applicant = GE HEALTHCARE JAPAN CORPORATION
510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC