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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Recall Number Z-1787-2013
Classification Class I
Code Info System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 0850260114, 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608775INF2, 608775INF3, 608791INF, 609267INF, 609652INF, 609730INF1, 609730INF2, 609835INFINIA, 610278INFINIA, 610327INFINIA, 610402INFINIA, 610402INFINIA2, 610437INFINIA, 610770INFINIA, 610869INF, 610954INFINIA, 613727INFIN, 613761INFINIA, 613969HAWKEYE, 613969INFINIA, 614478INF1, 615284INF1, 615322NM3, 615327VANM1, 615328NM1, 615342INF1, 615349NM1, 615349NM2, 615768SCNM1, 615769NM1, 615781NM1, 615893NM1, 615896NM1, 616267INFINIA, 617243INFINIA, 617296INF, 617313INF1, 618234INF1, 618256INF1, 618395INF, 618544INF, 618942INF, 618993INF, 619229INF, 619482INFINIA, 620225WPI, 620232INF, 623207INF, 623478NM2, 623848NM2, 623882INF, 626359INF1, 626359INF2, 626570INF1, 626573INF1, 626898INF1, 626915INF1, 63009NUC01, 630275INF, 630275INF2, 630312INF, 630545INF, 630786INF, 630801INF, 630856INF, 6502IN1, 6502IN2, 650367IN1, 650725IN, 650725IN2, 650858IN1, 650858IN2, 650858IN3, 651241INF1, 6525011INF1, 661633NM1, 661949NUC1, 661PMCNUC1, 662244INFINIA, 662256INFINIA, 662377INFINIA, 662423INFINIA, 662608NU01, 662772INFRM1, 662772INFRM2, 662772INFRM4, 671USNHINF, 678474INF, 681342INF1, 681342INF2, 681342INF3, 681342INF4, 70027NUC03, 70060NUC12, 701234INF, 701234INF2, 701364INF, 701774NM, 701857NM, 701952NM, 702255INF, 702360CHNM, 702369NM, 702388VNM, 702853NM, 703391INF1, 703391INF2, 703504HAWK1, 703558INF, 703689INF4, 703698INF1, 703858HAWK, 703858INF, 704225INF1, 704225INF2, 704304INF1, 704304INF2, 704316INFI, 704355INF1, 704355INF2, 704384HAWK1, 704384INFI2, 704384INFI4, 704384INFI5, 704384INH1, 704446INF1, 704487INFINIA1, 704660HAWK, 704667INF1, 704739INFI, 704783INFI1, 704783INFI2, 704783INFI3, 704863INF1, 705674HAWKEYE, 705674INFINIA, 705759HAWKEYE, 705759INFINIA2, 706278INF, 706291HINM, 706494HNM, 706651INF, 706651NUC, 706733INF, 707822INFINIA, 707963IN, 708660INF, 708684INF1, 708747INFACQ, 709637INFINIA1, 709651INFINIA, 709651INHE4A, 709737INFINIA, 709737INFINIA2, 709737INFINIA3, 712279INF, 713242INF1, 713242INF2, 713242INF3, 713359INF1, 713456INF, 713722INF, 713785SLINF1, 713785SLINF2, 713785SLINF3, 713794INF, 713794INF2, 713794INF3, 713ACCINF1, 714456INFINIA, 714953INFINIA, 715423INF, 715623INF, 715839INF, 716366INF, 717544INFINIA, 717627INFINIA, 717633INF1, 717633INF2, 717782INF, 718150INF1, 718240INF1, 718240INF2, 718250INF1, 718334INF1, 718334INF2, 718405INF1, 718518INF1, 718584INFINIA, 718616INF, 718630INF1, 718883INF1, 718883INF2, 718948INF, 718963INF1WH, 719333IH, 722050NU01, 724226INF1, 724357INF1, 724450INFINIA, 727461VG, 727521INF, 727581INF, 727843INF1, 727863INF1, 727893INF, 727942INF, 731425INFH1, 731425NMIC1, 731425NMRM, 731644INF, 732292INFINIA, 732321IH4, 732321INFINIA, 732530INFINIA, 732530INFINIA2, 732776INFH4, 732840INFINIA, 732923INFINIA, 732937INFINIA, 734246INF, 734467INF, 734475INF, 734671INF, 740264INF3, 740264INF4, 740356INF1, 740356INF2, 740383INF1, 740623INFINIA, 740922INFINIA, 740944NU01, 757259INF1, 757312INF1, 757312INF2, 757388INF2, 757395INF1, 757398INF1, 757398INF2, 757668INF1, 757722INF1, 757886INF1, 757889INF1, 760241INF1, 760452INF1, 760778INF1, 760873NUC, 763MRCYINFI, 763UNTYINFI, 765456INF, 765552INF, 770219INF, 770229INF, 770382INM, 770400INF, 770535INF1, 770751INF, 77137NUC01, 77139NUC05, 77187NUC01, 77260NUC03, 772LMCNM2, 773665INF1, 773665INF2, 77383NUC03, 773884INF, 773947INF, 773995INF, 774442INF, 775423INF1, 77624NUC01, 77624NUC03, 780489INFINIAH4, 780489INHE4B, 780489INHE4C, 780715INHE4A, 780875INFINIA, 781340INF, 781340INF2, 781340INF3, 781477INF, 781979INF1, 783348NU01, 785462CI, 786308INF1, 786308INF2, 787653INFINIA2, 787758INFINIA2, 787764INFINIA-1, 787848INFINIA, 78NMIH2564713, 801268INF1, 801299INF1, 801314INF1, 801357INF1, 801357INF2, 801387INF1, 801408INF, 801408INF2, 801465INF1, 801479INF, 801479INF2, 801501INF1, 801584INF1, 801584INF2, 801584INF3, 801588INF, 801ALTAINF2, 801IMCCARD, 801IMCINF, 801IMCINF1, 801RHINF, 801SLCINF, 802257INF, 802388INF, 802775INFINIA, 803329HAWK, 803329INFIN1, 804225INF1, 804254INF, 804281INF1, 804323INF1, 804594INF1, 804675INF1, 804957INF1, 804957INF2, 805370INF1, 805489INF1, 805543INF1, 805737INF1, 806354ACINFINIA, 806354NWINF, 806354NWINF2, 806GRACENM, 809758INFINIA, 812265KDINF, 812426INF, 812485INF, 812522INF, 812842INF1, 813788INF1, 813870INF, 813USFINF1, 814333INFINIA1, 814333INFINIA2, 814362INFINIA, 814452INF1, 814467INF, 814533INF, 814534INF1, 814643INF, 814723INF, 814877INFINIA, 814889INFINIA, 815395INF, 815432INF, 815432INFINIA, 815741INF1, 815741INF2, 815756INF, 816271SJINF, 816348INF1, 816380CASSINF, 816392RINF, 816404INF1, 816836CIIN, 817255INF, 817346INF, 817472INF, 817599INF, 817685INF, 817920INF, 818409INF2, 818884INF1, 818907INF1, 819357BINFINIA, 819378INFINIA, 819537INFINIA, 819537INFINIA2, 819563CINFINIA, 819595INFINIA, 828262INFINIA, 828286INFINIA, 828298HAWK1, 828298HAWK2, 828315HWK4, 828586INFINIA, 828696INFINIA1, 828766INFINIA, 828883INFINIA, 831755IN1, 832505NM1, 832522INF, 832522INF2, 832824INF, 843402INF, 843402INF2, 843412INF, 843431IN, 843606INF1, 843674IN1, 843674IN2, 843674IN3, 843689INF, 843692IN1, 843724INF, 843724INF2, 843777IN1, 843777IN2, 843777IN3, 843782INF, 843797INF1, 843832INF, 845794INFINIA, 845987INFINIA, 847480INF, 847535INFACQ, 847990INF1, 849010NU01, 850494HAWK, 850883ENM, 856247INF, 856363INFINIA, 858554EDCINF, 858554INF1, 858554INF2, 859268INF1, 859313INF, 859498INF1, 860344INF, 860350INIF, 863679INF1, 863680INF1, 863687INF1, 863687INF2, 864560HAWK1, 864675HAWK, 864675INFI, 864SPAHK1, 864SPAHK2, 865271NM1, 865373INF, 865429INFINIA, 865545INFINIA1, 865717INF, 865947INFINIA1, 865977INF, 876259NU01, 885INFI1, 885INFI2, 900010NU06, 901287INF1, 901495INFHAWK, 901495INFINIA, 901516NINFHK, 901516UINFHK, 901523INF1, 901523INF2, 901765INFRM8, 902567NUCINH4, 903416INF, 903731INFINIA, 903785INF, 903UTINF, 904202INF1, 904276INF1, 904321INF1, 904542NM, 904627INF1, 904627INF2, 904819INF1, 904821INF3, 904821NM1, 904821NM2, 905358INFINIA, 905372INFINIA, 905472INFINIA, 905472INHE4A, 905521INFHE4, 905522INFINIA, 905522INFINIA2, 905577INFHE4A, 905577INFHE4B, 905683IN1, 905731INFINIA, 905773INFINIA1, 905813INFINIA, 905813INFINIA2, 905832INFINIA, 905845INFINIA1, 905848INFINIA, 905855INFINIA, 905855INFINIA2, 905855INFINIA3, 905883HAWKEYE, 905895INFINIA1, 905895INFINIA2, 906293INF, 906774INF, 906776INF, 907562NM1, 907562NM2, 908522INFINIA, 908522INFINIA2, 908522INFINIA3, 909825INFINIA, 910323INF1, 912486EGNC, 912691SCNC, 913345INF1, 913541INF1, 913588INF, 913588INF1, 913588INF2, 913676SMIM, 915521HNM1, 915577NM1, 915595GNM1, 916453IN, 916537IN, 916537IN2, 916703IN1, 916703IN2, 916733IN, 916781IN, 916782IN1, 916782IN2, 916983INFN1, 918294INF1, 918307INF1, 918307INF2, 918376INF1, 918494INF1, 918494INF2, 918494INF3, 918502INF1, 918599INF1, 919684INF1, 919684INF2, 919684INF3, 919784INF1, 919934INF, 920288INF, 920288INF2, 920451INF, 920456INF, 920568INF, 920684INF, 920729INF, 920738INF, 920738INF1, 920738INF2, 920794INF, 920849INF, 920907INF, 925370IN, 925779IN, 925785IN, 925INF, 928214INF, 928442INF, 928537INF, 928855INF, 931381NM2, 931403NM1, 931967NM, 937208INF1, 937208INF2, 937268INF1, 937278INF, 937328INF1, 937328INF2, 937374INF1, 937386INF, 937390INF1, 937393INF, 937438INF, 937440INF1, 937440INF2, 937832INF1, 941235INF, 941629INF, 941637INF, 941766INF2, 941VRMCINF, 951672INF1, 951696INF1, 954265INF1, 954735INF1, 954735INF2, 954978INF1, 956350NM1, 956687INF2, 956971NM1, 970350IH, 970945INF, 972394INF, 972498INF, 972540INF, 972596INF, 972969INF, 973579INFINIA, 973625INFINIA, 973676INFINIA, 973831INFINIA, 973877INFINIA, 973971INFINIA, 978521INF, 979241INF, 979532INF1, 980212INF1, 985230INF, 985646INF, 985649INF1, 985649INF2, 985785INF, 989723INF1, 989723INF2, A004NU11, A186363001, A4169304, A4194407, A51043155, A51043187, A5107756, A5107766, A5109126, A5109665, A5109666, A5111127, A5111240, A5112411, A5113627, A5114292, A51149103, A5115111, A51152163, A51152164, A5118056, A5118088, A5120724, A5123523, A5124139, A5127292, A5128755, A5128757, A5129026, A5129959, A5152964, A5153612, A5162248, A5172907, A5172908, A5178021, A5181660, A5181662, A5189714, A5197927, A5197934, A5198016, A5215935, A5216823, A5216824, A5224207, A5267107, A5279301, A5279302, A5306502, A5315551, A5352208, A5367805, A5547414, A5634003, A5649008, A5719812, A58080111, A58080134, A5924402, A99263311, AC001NU14, AC001NU18, AF1026NM01, AH1908NU01, AH1908NU02, AH3403NU01, AH3701NM05, AH4307NM05, AH4660NM06, AH5117NU02, AH5249NM04, AH5293NM04, AH5689NU01, AH5689NU03, AH5689NU04, AH5844NM05, ALM0131, AMS0338, APL0232, ARHINFI, B1650218, B1768001, B4155415, B4182004, B5119121, B5142302, B5142304, B5174320, B5315345, B5357630, B5365422, B5395703, B5483443, B5618331, BCHINF1, BRMCINF, C001NU06, C001NU10, C4191749, C4191765, C5120912, C5120915, CC3899NU01, CE561221, CFRHINF, CHAM01NU01, COR359309, COR369576, COR373273, COR373282, CRAVENINF1, CRAVENINF2, CRAVENINF3, CS1008NM03, CS1021NM03, CS1052NM08, CS1052NM09, CS1277NM01, CS1277NM02, CS1318NM01, CSNMINFINIA, CY1015NM01, D5111602, D5111607, DE492A51, DE528467, DE539254, DE6588112, DEH13556, DEN01721, DEN01723, DEN01725, DEN01727, DHG0539, DK1022NM05, DK1023NM03, DK1023NM05, DK1026NM07, DK1026NM08, DK1029NM05, DK1065NM04, DK1065NM05, DPN00002, DVT0138, DZ1035NM03, DZ1035NM04, DZ1147NM01, DZ1279NM01, DZ1338NM01, E001NU16, E4858901, EE1019NM02, EE238526, EEF51540, EG1100MN01, EG1124MN02, EG1538MN01, EG1826MN01, EMM0131, F5119151, FE443890, FEB33835, FEE12426, FEG46134, FHEINF, FI1000MN04, FI1003MN05, FI1003MN06, FI1010NM01, FI1019MN01, FI1021MN01, FI1023MN02, FI1029MN01, FI1064MN01, FI1153MN01, FPG86405, G4191710, GE1004NM01, GILESINF, GOLD001642, GOLD010343, GOU0137, GOU0138, GPQ19105, H002NU01, H010NU04, H010NU08, H2094NUC07, H2094NUC28, H2100NUC02, H2193NUC13, H4858974, HC0074NU01, HC0507NU03, HC0842NU01, HC0863NU01, HC0892NU04, HC1249NU01, HC1249NU02, HC1819NU01, HC2252NU01, HC2720NU02, HC3442NU01, HC4387NU02, HC4480NU01, HC7475NU03, HDB0130, HGL0233, HGV0130, HLUE01NU01, HLV0334, HR4103NM01, HU1039NM02, HU1099NM01, IE1006MN04, IE1029MN04, IE1029MN05, IE1053MN01, IE1085MN05, IE1100MN01, IE1110MN01, IE1510MN09, IE1510MN12, IE1510MN16, IE1564NM01, IE1564NM03, IL1018NM07, IL1018NM08, IL1020NM25, IL1020NM31, IL1028NM26, IL1041NM18, IL1041NM22, IL1041NM28, IL1041NM29, IL1042NM09, IL1043NM20, IL1059NM07, IL1062NM26, IL1068NM05, IL1069NM06, IL1069NM11, IL1331NM01, INF2649553, IR1049NM01, IR1501NM01, JO1034NM01, JOHNINF, KW1001MN23, KW1001MN25, KW1005MN11, KW1005MN14, KW1006NM01, KW1013NM01, KW1013NM02, KW1018MN05, KW1018MN06, KW1018MN08, LB1122NM02, LDD0431, LDD0433, LGMCINF, LGMCINF2, LT4000MN01, LT4000MN02, LV4002NM02, M1106608, M1279727, M1400803, M1804913, M1804914, M204493801, M2147255, M218669001, M2269829, M23084315, M256517203, M2645705, M2846905, M4018099, M4018536, M4023087, M4024095, M40345193, M4040544, M4111216, M4135141, M4135145, M4143953, M4144332, M4144340, M4145143, M4159227, M4159228, M4159235, M4159460, M4160449, M4163763, M4167153, M4184856, M4191430, M4194031, M4198189, M4215553, M4234232, M4234235, M4479619, M4480229, M4480232, M44827146, M4496943, M5172527, M54606103, M7411101, M7411106, M8572211, M9162716, M9164758, M9319116, M9886832, MA1020NM01, MA1272NM01, MA1439NM01, ME051533, ME208350, ME244391, ME244393, MEX68919, MPP0131, MPX46902, MPX47106, MPX52309, MPX82204, MPX99201, MQ1000MN04, MT1014NM01, MT1014NM02, MVINFNM2, N001NU02, N001NU06, NA1027NM01, NASHNM2, NE209938, NM156449, NM18342, NM18346, NM18356, NM18357, NM18363, NM18365, NM18409, NM18444, NM18451, NM18471, NMCR-17849, NMCR-17980, NMINDTCRL0206, NMINDTCRL0227, NMINDTCRL0311, NMINDTCRL0351, NO1000MN03, NO1000MN06, NO1016MN16, NO1054MN01, NO1068MN07, NO1068MN09, NO1070MN07, NO1088MN09, NO1116MN09, NP739716, NPV15964, NUC5178133HM6, O005NU14, OBNM1, ORMCINFINIA1, ORMCINFINIA2, P4211482, PC1268NU03, PC1818NU03, PC3906NU02, PC3964NU02, PC3970NU02, PC5995NU01, PC8118NU01, PER03520, PER08009, PITTINF4, PITTINF5, PK1001NM01, PK1031NM01, PK1032NM01, PK1180NM03, PK1180NM08, PK1184NM01, PK1278NM01, PK1307NM01, PK1335NM01, PK1336NM01, PK1355NM01, PL1003NM03, PL1143NM03, PL1143NM06, PL1692NM01, PM1633NU03, PMR12506, PPR08202, PPR12213, PPR59030, PPR97306, PPS06907, PRINCEINF, R4211480, RO1224NM01, RU1018NM01, RU1021NM02, RU1085NM02, RU1091NM01, RU1095NM02, RU1152NM02, RU1212NM01, RU1284NM01, RU1294NM01, RU1302NM01, RU2050NM01, RU2199NM01, RU2311NM01, RU2311NM02, RU2526NM01, RU2527NM02, RU2527NM03, RU3143NM02, RU3314NM01, RU3424NM01, RU3448NM01, RU3508NM01, S4160059, S4160079, SA1001MN01, SA2146NM01, SLGHINF, TN1366NM01, UC4109NU02, UC7655NU03, UC7655NU04, UE282633, UE282648, UE720407, UEW19003, UEW19005, UK1110NM01, UK5002NM01, UP285A41, UPW00402, V1471114, V2147210, V2728105, V2728109, V2943412, V2943415, V4198004, V6414104, V7405209, V7406615, V7406617, V8572204, VASINF, VCWESTINF, VVMCINF1, X100611101, X105967809, X105967813, X119197203, X151957601, X2034002, X4211026, X59007307, X61014001, Y004NU08, Y004NU11, YE364413, YE364417, YE626937, YN1196, YN1200, YN1539, YN1540, YN1541, YN1542, YN1543, YN1544, YN1545, YN1546, YN1547, YN1548, YN1549, YN1550, YN1551, YN1552, YN1553, YN1554, YN1555, YN1556, YN1557, YN1558, YN1559, YN1560, YN1561, YN1562, YN1563, YN1564, YN1565, YN1566, YN1567, YN1568, YN1569, YN1570, YN1571, YN1572, YN1573, YN1574, YN1575, YN1577, YN1578, YN1579, YN1580, YN1581, YN1582, YN1583, YN1584, YN1585, YN1586, YN1587, YN1588, YN1589, YN1590, YN1591, YN1592, YN1593, YN1594, YN1595, YN1596, YN1597, YN1598, YN1599, YN1600, YN1601, YN1641, YN1650, YN1730, YN1742, YN1743, YN1744, YN1745, YN1760, YN1802, YN4218, YN4219, YN4220, YN4221, YN4222, YN4223, YN4224, YN4225, YN4226, YN4227, YN4228, YN4229, YN4230, YN4231, YN4232, YN4233, YN4234, YN4235, YN4236, YN4237, YN4238, YN4239, YN4240, YN4241, YN4242, YN4243, YN4244, YN4245, YN4248, YN4249, YN4250, YN4251, YN4252, YN4253, YN4254, YN4255, YN4256, YN4257, YN4258, YN4259, YN4260, YN4261, YN4262, YN4263, YN4264, YN4265, YN4266, YN4267, YN4270, YN4280, YN4288, YN4300, YN4312, YN4818, YN4819, YN4820, YN4821, YN4822, YN4824, YN4825, YN4830, YN4833, YN4900, YN4918, YN4919, YN4920, YN4921, YN4922, YN4923, YN4924, YN4925, YN4926, YN4927, YN4928, YN4929, YN4930, YN4931, YN4932, YN4933, YN4934, YN4935, YN4936, YN4937, YN4938, YN4939, YN4941, YN4942, YN4943, YN4944, YN4945, YN4946, YN4947, YN4948, YN4949, YN4950, YN4951, YN4952, YN4953, YN4954, YN4955, YN4990, YN4992, YN4999, YN5000, YN8001, YN8002, YN8003, Z001NU06, ZA1806NM12, ZA1807NM11, ZA1808NM13, ZA1820NM04, ZA1835NM24, ZA1835NM25, ZA2006NM04, ZA2008NM04, ZA2212NM02, ZA2246NM01, ZA2261NM01, ZTP0133, ZWL0437.
Product Distributed Qty 2474
Reason For Recall GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

Event Detail

Event Id 65579
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
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