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Class 1 Recall
Infinia
21
Date Posted
July 24, 2013
Recall Status1
Open
Recall Number
Z-1787-2013
Premarket Notification
510(K) Numbers
K02296022
K05243423
K99184124
Product Classification
System, Tomography, Computed, Emission25 - Product Code

KPS26
Product
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.
Code Information
System ID: 1153389, 1299296, 2555007, 2621801, 2638808,

2694593, 2760723, 2768147, 2769200, 2775945, 2812777,
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03-01-2014 10:17
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0850260091, 0850260092, 0850260093, 0850260094,

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03-01-2014 10:17
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03-01-2014 10:17
4 de 15
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03-01-2014 10:17
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03-01-2014 10:17
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03-01-2014 10:17
7 de 15
623882INF, 626359INF1, 626359INF2, 626570INF1,

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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,
03-01-2014 10:17
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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,
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,
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,
03-01-2014 10:17
9 de 15
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,
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,
973625INFINIA, 973676INFINIA, 973831INFINIA,
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,
03-01-2014 10:17
10 de 15
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,
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,
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,
03-01-2014 10:17
11 de 15
PRINCEINF, R4211480, RO1224NM01, RU1018NM01,

RU1021NM02, RU1085NM02, RU1091NM01, RU1095NM02,
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.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
For Additional
Information Contact
technical services
262-513-4122
03-01-2014 10:17
12 de 15
Manufacturer 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.
FDA Determined
DESIGN: Device Design
Cause
Action
GE sent an Urgent Medical Device Correction letter dated June

17, 2013 to all affected customers. The letter identified the
affected product, recommended that qualified service personnel
maintain the equipment and that Preventative Maintenance
procedures are executed according to labeling. Also the Safety
Chapter Sections should be re-reviewed with personnel to
ensure proper operation of the equipment. GE notified customers
again on July 03, 2013, via Urgent Medical Device Recall letter
(including confirmation of delivery for US customers) and
follow-up telephone call. Customers were instructed to cease
using the affected system until GE Healthcare Field Engineer can
complete an inspection of the system and perform any
necessary repairs at no cost. A GE Healthcare representative
will contact the hospitals to arrange for the inspection.
Quantity in Commerce
2474
Distribution
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.
Total Product Life Cycle
TPLC Device Report27
For details about termination of a recall see Code of Federal Regulations (CFR) Title 21
7.5528
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 = KPS and Original Applicant =

GE MEDICAL SYSTEMS29
510(K)s with Product Code = KPS and Original Applicant =
GE MEDICAL SYSTEMS F.I. HAIFA30
03-01-2014 10:17
13 de 15
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16. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
17. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm
18. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
19. /scripts/cdrh/cfdocs/cfClia/Search.cfm
20. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
21. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs
/relateditems.cfm?page_title=medical%20device%20recalls&
item1_text=%3Ch3%3Erelated%20recalls%20for%20Infinia%3C%2Fh3%3E&
item1_url=www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres
/res.cfm?start_search=1&event_id=65579&
item2_text=medical%20device%20recalls%20&item2_url=www.fda.gov
/medicaldevices/safety/recallscorrectionsremovals/listofrecalls/default.htm&
item3_text=fda%20enforcement%20report%20index&item3_url=www.fda.gov
/safety/recalls/enforcementreports/default.htm
22. /scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K022960
25. /scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KPS
27. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=KPS
28. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=7.55
29. ../cfPMN/pmn.cfm?start_search=1&productcode=KPS&
applicant=GE%20MEDICAL%20SYSTEMS
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6. /scripts/cdrh/devicesatfda/index.cfm
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16. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
17. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm
18. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
19. /scripts/cdrh/cfdocs/cfClia/Search.cfm
20. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
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21. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs
/relateditems.cfm?page_title=medical%20device%20recalls&
item1_text=%3Ch3%3Erelated%20recalls%20for%20Infinia%3C%2Fh3%3E&
item1_url=www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres
/res.cfm?start_search=1&event_id=65579&
item2_text=medical%20device%20recalls%20&item2_url=www.fda.gov
/medicaldevices/safety/recallscorrectionsremovals/listofrecalls/default.htm&
item3_text=fda%20enforcement%20report%20index&item3_url=www.fda.gov
/safety/recalls/enforcementreports/default.htm
27. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=KPS
28. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=7.55
applicant=GE%20MEDICAL%20SYSTEMS
applicant=GE%20MEDICAL%20SYSTEMS%20F%2EI%2E%20HAIFA
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