Class 2 Device Recall GE Healthcare Infinia

• Date Initiated by Firm: December 18, 2024
• Date Posted: January 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0899-2025
• Recall Event ID: 96079
• 510(K)Number: K022960
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
• Code Information: 1) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID M348992912, Serial Number 17033. 5) H3000WC: UDI/DI N/A, System ID 907562HK4, Serial Number 18610; UDI/DI N/A, System ID 907562HK4, Serial Number 18643; UDI/DI N/A, System ID 205783INF1, Serial Number 17571; UDI/DI N/A, System ID 479553INF, Serial Number 18470; UDI/DI N/A, System ID 479441INF1, Serial Number 17301; UDI/DI N/A, System ID 928855INF, Serial Number 17190; UDI/DI N/A, System ID 480512INF1, Serial Number 17019; UDI/DI N/A, System ID 602406INF1, Serial Number 18422; UDI/DI N/A, System ID 602406INF3, Serial Number 18465; UDI/DI N/A, System ID 480323INFRM3, Serial Number 17488; UDI/DI N/A, System ID 480882INF1, Serial Number 18026; UDI/DI N/A, System ID 530888IN1, Serial Number 18579; UDI/DI N/A, System ID 760873NUC, Serial Number 17290; UDI/DI N/A, System ID 6502IN1, Serial Number 17680; UDI/DI N/A, System ID 916537IN2, Serial Number 17264; UDI/DI N/A, System ID 510537IN1, Serial Number 18280; UDI/DI N/A, System ID 626915INF1, Serial Number 16946; UDI/DI N/A, System ID 209223IN, Serial Number 18308; UDI/DI N/A, System ID 559353IN, Serial Number 17995; UDI/DI N/A, System ID 626573INF1, Serial Number 17410; UDI/DI N/A, System ID 510400IN, Serial Number 17108; UDI/DI N/A, System ID 530533IN, Serial Number 18531; UDI/DI N/A, System ID 916782IN1, Serial Number 17973; UDI/DI N/A, System ID 916782IN2, Serial Number 17987; UDI/DI N/A, System ID 916453IN, Serial Number 17373; UDI/DI N/A, System ID 916703IN2, Serial Number 17699; UDI/DI N/A, System ID 916733IN, Serial Number 18460; UDI/DI N/A, System ID 415838IN, Serial Number 17269; UDI/DI N/A, System ID 415353IN2, Serial Number 18305; UDI/DI N/A, System ID 4082IN, Serial Number 17392; UDI/DI N/A, System ID 408315IN, Serial Number 17579; UDI/DI N/A, System ID 408259IN2, Serial Number 18619; UDI/DI N/A, System ID 707576IN, Serial Number 18583; UDI/DI N/A, System ID 6525011INF1, Serial Number 16975; UDI/DI N/A, System ID 203688INF, Serial Number 16820; UDI/DI N/A, System ID 202715INF4, Serial Number 17265; UDI/DI N/A, System ID 561744INF2, Serial Number 18515; UDI/DI N/A, System ID 863680INF1, Serial Number 17331; UDI/DI N/A, System ID 954735INF1, Serial Number 16925; UDI/DI N/A, System ID 904276DSC1, Serial Number 17243; UDI/DI N/A, System ID 404605INF, Serial Number 17485; UDI/DI N/A, System ID 706651INF, Serial Number 18430; UDI/DI N/A, System ID 478633INFINIA2, Serial Number 17502; UDI/DI N/A, System ID 770400INF, Serial Number 18435; UDI/DI N/A, System ID 515247INF1, Serial Number 18314; UDI/DI N/A, System ID 515247INF2, Serial Number 18338; UDI/DI N/A, System ID 712279INF, Serial Number 18307; UDI/DI N/A, System ID 312996INF, Serial Number 17960; UDI/DI N/A, System ID 217223INF2, Serial Number 17053; UDI/DI N/A, System ID 317338HAWK, Serial Number 17389; UDI/DI N/A, System ID 812265KDINF, Serial Number 18490; UDI/DI N/A, System ID 785462CI, Serial Number 17702; UDI/DI N/A, System ID 913588INF2, Serial Number 18024; UDI/DI N/A, System ID 620232INF, Serial Number 18425; UDI/DI N/A, System ID 316268VCFI, Serial Number 17122; UDI/DI N/A, System ID VCWESTINF, Serial Number 17940; UDI/DI N/A, System ID VCHARRYINF, Serial Number 18553; UDI/DI N/A, System ID 270745INF1, Serial Number 18571; UDI/DI N/A, System ID 859239INF, Serial Number 18575; UDI/DI N/A, System ID 270659INF, Serial Number 17156; UDI/DI N/A, System ID 270651INF1, Serial Number 18312; UDI/DI N/A, System ID 225761NM1, Serial Number 18614; UDI/DI N/A, System ID 337289INF, Serial Number 17020; UDI/DI N/A, System ID 617296INF, Serial Number 16977; UDI/DI N/A, System ID 508427INF2, Serial Number 17510; UDI/DI N/A, System ID 508674INFINIA, Serial Number 16987; UDI/DI N/A, System ID 410822HK1, Serial Number 17633; UDI/DI N/A, System ID 301714INF, Serial Number 18047; UDI/DI N/A, System ID 313343INF1, Serial Number 17318; UDI/DI N/A, System ID 313745INF, Serial Number 18588; UDI/DI N/A, System ID 313473INF, Serial Number 18502; UDI/DI N/A, System ID 586416INF, Serial Number 16821; UDI/DI N/A, System ID 248465INF, Serial Number 17381; UDI/DI N/A, System ID 231935INF, Serial Number 18181; UDI/DI N/A, System ID 507OLMINF1, Serial Number 18230; UDI/DI N/A, System ID 507402INF1, Serial Number 17581; UDI/DI N/A, System ID 816404INF1, Serial Number 18082; UDI/DI N/A, System ID 816271SJINF, Serial Number 17442; UDI/DI N/A, System ID 314525INF2, Serial Number 16811; UDI/DI N/A, System ID 228523HWK, Serial Number 17737; UDI/DI N/A, System ID 662377INFINIA, Serial Number 17358; UDI/DI N/A, System ID 828315HWK4, Serial Number 17105; UDI/DI N/A, System ID 701364INFHE4, Serial Number 17181; UDI/DI N/A, System ID 701234INF, Serial Number 18135; UDI/DI N/A, System ID 402354HWK, Serial Number 16962; UDI/DI N/A, System ID 973676INFINIA, Serial Number 18121; UDI/DI N/A, System ID 732321IH4, Serial Number 18098; UDI/DI N/A, System ID 732776INFH4, Serial Number 18183; UDI/DI N/A, System ID 732937INFINIA, Serial Number 17412; UDI/DI N/A, System ID 505609INFINIA, Serial Number 17638; UDI/DI N/A, System ID 702360CHNM, Serial Number 17002; UDI/DI N/A, System ID 518626INF, Serial Number 17494; UDI/DI N/A, System ID 718405INF1, Serial Number 17655; UDI/DI N/A, System ID 718616INF, Serial Number 16874; UDI/DI N/A, System ID 718963INF1WH, Serial Number 16889; UDI/DI N/A, System ID 718240INF2, Serial Number 17299; UDI/DI N/A, System ID 718250INF1, Serial Number 17804; UDI/DI N/A, System ID 718150INF1, Serial Number 18193; UDI/DI N/A, System ID 718334INF2, Serial Number 16949; UDI/DI N/A, System ID 718334INF1, Serial Number 16950; UDI/DI N/A, System ID 518926INF, Serial Number 18180; UDI/DI N/A, System ID 607274INF, Serial Number 17447; UDI/DI N/A, System ID 607274INF2, Serial Number 17637; UDI/DI N/A, System ID 718883INF2, Serial Number 18294; UDI/DI N/A, System ID 718883INF1, Serial Number 18330; UDI/DI N/A, System ID ORMCINFINIA1, Serial Number 18126; UDI/DI N/A, System ID 212686INF1, Serial Number 17890; UDI/DI N/A, System ID 212989INF1, Serial Number 18060; UDI/DI N/A, System ID 845348INF, Serial Number 16622; UDI/DI N/A, System ID 516562INFINIA1, Serial Number 17330; UDI/DI N/A, System ID COR359309, Serial Number 17187; UDI/DI N/A, System ID 330363INFINIA1, Serial Number 16808; UDI/DI N/A, System ID 937438INF, Serial Number 17124; UDI/DI N/A, System ID 937832INF1, Serial Number 17382; UDI/DI N/A, System ID 330386D630, Serial Number 17145; UDI/DI N/A, System ID 419423NUC, Serial Number 18282; UDI/DI N/A, System ID 419383NM1, Serial Number 17922; UDI/DI N/A, System ID 419251INFINIA, Serial Number 18551; UDI/DI N/A, System ID 937440INF1, Serial Number 17531; UDI/DI N/A, System ID 513298INF2, Serial Number 17634; UDI/DI N/A, System ID 513298INF1, Serial Number 17650; UDI/DI N/A, System ID 918756INF, Serial Number 17937; UDI/DI N/A, System ID 918376INF1, Serial Number 16871; UDI/DI N/A, System ID 918599INF1, Serial Number 18412; UDI/DI N/A, System ID 541754HK4, Serial Number 18337; UDI/DI N/A, System ID 541387INF, Serial Number 17174; UDI/DI N/A, System ID 503561HK4, Serial Number 17575; UDI/DI N/A, System ID 541296HK4, Serial Number 17926; UDI/DI N/A, System ID 610402INFINIA2, Serial Number 17654; UDI/DI N/A, System ID 412653INF1, Serial Number 18343; UDI/DI N/A, System ID 814946INF, Serial Number 18602; UDI/DI N/A, System ID 814362INFINIA, Serial Number 18171; UDI/DI N/A, System ID 484503INFINIA1, Serial Number 18205; UDI/DI N/A, System ID 814877INFINIA, Serial Number 18348; UDI/DI N/A, System ID 717633INF1, Serial Number 17598; UDI/DI N/A, System ID 717633INF2, Serial Number 17615; UDI/DI N/A, System ID 570501INF, Serial Number 17786; UDI/DI N/A, System ID 724357INF1, Serial Number 17896; UDI/DI N/A, System ID 814534INF1, Serial Number 18472; UDI/DI N/A, System ID 215710INFINIA, Serial Number 17058; UDI/DI N/A, System ID 610377INFINIA, Serial Number 18278; UDI/DI N/A, System ID 814333INFINIA, Serial Number 18093; UDI/DI N/A, System ID 412372INF1, Serial Number 18359; UDI/DI N/A, System ID 610278INFINIA, Serial Number 17801; UDI/DI N/A, System ID 215427INFINIA, Serial Number 17758; UDI/DI N/A, System ID 215728INFINIAJ, Serial Number 18000; UDI/DI N/A, System ID 215707INFINIA, Serial Number 18007; UDI/DI N/A, System ID 412692INF1, Serial Number 17567; UDI/DI N/A, System ID 412692INF2, Serial Number 17580; UDI/DI N/A, System ID 570621INF2, Serial Number 18482; UDI/DI N/A, System ID 570552INF, Serial Number 17042; UDI/DI N/A, System ID 401444INF, Serial Number 17809; UDI/DI N/A, System ID 401793860NM, Serial Number 18141; UDI/DI N/A, System ID 864560HAWK1, Serial Number 17813; UDI/DI N/A, System ID 864675HAWK, Serial Number 17509; UDI/DI N/A, System ID 803329HAWK, Serial Number 17262; UDI/DI N/A, System ID 864SPAHK1, Serial Number 17916; UDI/DI N/A, System ID 864SPAHK2, Serial Number 17977; UDI/DI N/A, System ID 423778MMINF, Serial Number 17005; UDI/DI N/A, System ID 423778EDINF, Serial Number 17034; UDI/DI N/A, System ID 423553INF, Serial Number 17349; UDI/DI N/A, System ID 423472INF, Serial Number 17497; UDI/DI N/A, System ID 731425INFH1, Serial Number 17522; UDI/DI N/A, System ID 865271NM1, Serial Number 17098; UDI/DI N/A, System ID 901516UINFHK, Serial Number 17517; UDI/DI N/A, System ID 901516NINFHK, Serial Number 17703; UDI/DI N/A, System ID 615769NM1, Serial Number 17668; UDI/DI N/A, System ID 731644INFHK, Serial Number 18580; UDI/DI N/A, System ID 512397INF, Serial Number 17207; UDI/DI N/A, System ID 979241INF, Serial Number 18516; UDI/DI N/A, System ID 281420INF, Serial Number 17348; UDI/DI N/A, System ID 361881SSINF1, Serial Number 17400; UDI/DI N/A, System ID 214370INF, Serial Number 18105; UDI/DI N/A, System ID 817920INF, Serial Number 18413; UDI/DI N/A, System ID 713ACCINF1, Serial Number 16887; UDI/DI N/A, System ID 713456INF, Serial Number 17677; UDI/DI N/A, System ID 254519NMINF, Serial Number 16938; UDI/DI N/A, System ID 361595SKI1, Serial Number 18325; UDI/DI N/A, System ID 512LRMCNM, Serial Number 18326; UDI/DI N/A, System ID 832505NM1, Serial Number 17759; UDI/DI N/A, System ID 956971NM1, Serial Number 17217; UDI/DI N/A, System ID 972540INF, Serial Number 17191; UDI/DI N/A, System ID 469764INF, Serial Number 18380; UDI/DI N/A, System ID 817255INF, Serial Number 18057; UDI/DI N/A, System ID 972596INF, Serial Number 18001; UDI/DI N/A, System ID 281274DINF, Serial Number 18561; UDI/DI N/A, System ID 903UTINF, Serial Number 17704; UDI/DI N/A, System ID 801ALTAINF2, Serial Number 18170; UDI/DI N/A, System ID 801299INF1, Serial Number 17573; UDI/DI N/A, System ID VVMCINF1, Serial Number 17574; UDI/DI N/A, System ID 801IMCINF, Serial Number 17103; UDI/DI N/A, System ID 801387INF1, Serial Number 18208; UDI/DI N/A, System ID 801357INF2, Serial Number 17954; UDI/DI N/A, System ID 801RHINF, Serial Number 17707; UDI/DI N/A, System ID 801SLCINF, Serial Number 17260; UDI/DI N/A, System ID 801408INF2, Serial Number 18169; UDI/DI N/A, System ID 435781INF1, Serial Number 17967; UDI/DI N/A, System ID JOHNINF, Serial Number 17903; UDI/DI N/A, System ID 703504HAWK1, Serial Number 18474; UDI/DI N/A, System ID 703391INF2, Serial Number 18353; UDI/DI N/A, System ID 540332INF1, Serial Number 17092; UDI/DI N/A, System ID 540332INF3, Serial Number 18489; UDI/DI N/A, System ID 703858HAWK, Serial Number 17572; UDI/DI N/A, System ID 703689INF4, Serial Number 17037; UDI/DI N/A, System ID 540741HAWK1, Serial Number 17664; UDI/DI N/A, System ID 757395INF1, Serial Number 18113; UDI/DI N/A, System ID 540536OCHAWK, Serial Number 17384; UDI/DI N/A, System ID 802257INF, Serial Number 17532; UDI/DI N/A, System ID 802388INF, Serial Number 18090; UDI/DI N/A, System ID 425261INF, Serial Number 18139; UDI/DI N/A, System ID 360PSPHINF1, Serial Number 17135; UDI/DI N/A, System ID 206223INF2, Serial Number 17985; UDI/DI N/A, System ID 715623INF, Serial Number 18373; UDI/DI N/A, System ID 920738INF1, Serial Number 18028; UDI/DI N/A, System ID 920738INF2, Serial Number 18107; UDI/DI N/A, System ID 262741INF2, Serial Number 17226; UDI/DI N/A, System ID 920568INF, Serial Number 17770; UDI/DI N/A, System ID 920568INF, Serial Number 18153; UDI/DI N/A, System ID 414325INF, Serial Number 17326; UDI/DI N/A, System ID 262329INF, Serial Number 17569; UDI/DI N/A, System ID DE492A51, Serial Number 18143; UDI/DI N/A, System ID 608775INF3, Serial Number 18459; UDI/DI N/A, System ID 608263INF3, Serial Number 18327; UDI/DI N/A, System ID 414649INF, Serial Number 17050; UDI/DI N/A, System ID 608324INF, Serial Number 18329; UDI/DI N/A, System ID 920729INF, Serial Number 17491; UDI/DI N/A, System ID 262569INF, Serial Number 18418; UDI/DI N/A, System ID 920456INF, Serial Number 17649; UDI/DI N/A, System ID 262656INF1, Serial Number 17659; UDI/DI N/A, System ID 262687INF, Serial Number 16774; UDI/DI N/A, System ID 262687INF2, Serial Number 17068; UDI/DI N/A, System ID 262434INF1, Serial Number 17714; UDI/DI N/A, System ID 262434INF2, Serial Number 17841; UDI/DI N/A, System ID 262928INF, Serial Number 18508; UDI/DI N/A, System ID 715423INF, Serial Number 18513; UDI/DI N/A, System ID PRINCEINF, Serial Number 18400; UDI/DI N/A, System ID 1577INFINIA, Serial Number 17398; UDI/DI N/A, System ID NM18444, Serial Number 18444; UDI/DI N/A, System ID NM18509, Serial Number 18509; UDI/DI N/A, System ID NM18477, Serial Number 18477; UDI/DI N/A, System ID NM17328, Serial Number 17328; UDI/DI N/A, System ID 2962725INFINIA, Serial Number 18236; UDI/DI N/A, System ID 2954INFINIA, Serial Number 17546; UDI/DI N/A, System ID 0910264112, Serial Number 17729; UDI/DI N/A, System ID 0910262335, Serial Number 17950; UDI/DI N/A, System ID 0910262338, Serial Number 18376; UDI/DI N/A, System ID 0910262301, Serial Number 18075; UDI/DI N/A, System ID 0910262263, Serial Number 17627; UDI/DI N/A, System ID 0910262276, Serial Number 17732; UDI/DI N/A, System ID 0910264137, Serial Number 18411; UDI/DI N/A, System ID 0910262244, Serial Number 17481; UDI/DI N/A, System ID 0910262255, Serial Number 17588; UDI/DI N/A, System ID 0910262293, Serial Number 17907; UDI/DI N/A, System ID 0910262312, Serial Number 18116; UDI/DI N/A, System ID 0910262288, Serial Number 17825; UDI/DI N/A, System ID 0910262291, Serial Number 17882; UDI/DI N/A, System ID 0910264115, Serial Number 17905; UDI/DI N/A, System ID 0910264126, Serial Number 18184; UDI/DI N/A, System ID 0910264107, Serial Number 17756; UDI/DI N/A, System ID 0910265068, Serial Number 17906; UDI/DI N/A, System ID 0910265072, Serial Number 18111; UDI/DI N/A, System ID 0910264136, Serial Number 18332; UDI/DI N/A, System ID 0910263210, Serial Number 17570; UDI/DI N/A, System ID AH5689NU03, Serial Number 17388; UDI/DI N/A, System ID AH1908NU01, Serial Number 17613; UDI/DI N/A, System ID 910264091, Serial Number 17286; UDI/DI N/A, System ID 190052NU06, Serial Number 17061; UDI/DI N/A, System ID 110064NU01, Serial Number 17643; UDI/DI N/A, System ID 030240NU07, Serial Number 17416; UDI/DI N/A, System ID 190171NU05, Serial Number 17994; UDI/DI N/A, System ID 030232NU13, Serial Number 16910; UDI/DI N/A, System ID 030151NU12, Serial Number 17619; UDI/DI N/A, System ID 031994NU01 or 080038NU09, Serial Number 17377; UDI/DI N/A, System ID 2760723, Serial Number 17500; UDI/DI N/A, System ID NMINDTCRL0227, Serial Number 18172; UDI/DI N/A, System ID 2775945, Serial Number 17603; UDI/DI N/A, System ID 2694593, Serial Number 17194; UDI/DI N/A, System ID 2768147, Serial Number 17594; UDI/DI N/A, System ID NM18357, Serial Number 18357; UDI/DI N/A, System ID 2638808, Serial Number 17028; UDI/DI N/A, System ID 2621801, Serial Number 17032; UDI/DI N/A, System ID 403670NUC8, Serial Number 17137; UDI/DI N/A, System ID 403289NUC2, Serial Number 18081; UDI/DI N/A, System ID 780489INHE4B, Serial Number 17778; UDI/DI N/A, System ID 780715INHE4A, Serial Number 18423; UDI/DI N/A, System ID 780489INHE4C, Serial Number 18217; UDI/DI N/A, System ID 403382INFINIA1, Serial Number 16849; UDI/DI N/A, System ID 604557INFINIAH1, Serial Number 17241; UDI/DI N/A, System ID 604557INFINIAH3, Serial Number 17249; UDI/DI N/A, System ID 604557INFINIAH2, Serial Number 17258; UDI/DI N/A, System ID 604520INFINIA4H, Serial Number 17104; UDI/DI N/A, System ID 250565NUC4, Serial Number 17029; UDI/DI N/A, System ID 604228INFINIA1, Serial Number 17323; UDI/DI N/A, System ID 250370INFINIAH4, Serial Number 17169; UDI/DI N/A, System ID 250727INFINIA1, Serial Number 17195; UDI/DI N/A, System ID 403251INFINIA1, Serial Number 17101; UDI/DI N/A, System ID 403777INFINIA, Serial Number 17300; UDI/DI N/A, System ID 204787INFINIA2, Serial Number 17974; UDI/DI N/A, System ID 506739INFINIA2, Serial Number 18159; UDI/DI N/A, System ID 709651INHE4A, Serial Number 18016; UDI/DI N/A, System ID 709737INFINIA2, Serial Number 16869; UDI/DI N/A, System ID 902567NUCINH4, Serial Number 17297; UDI/DI N/A, System ID 519752INFINIAH4, Serial Number 16927; UDI/DI N/A, System ID 905577INFHE4B, Serial Number 17452; UDI/DI N/A, System ID 905577INFHE4A, Serial Number 17476; UDI/DI N/A, System ID 905521INFHE4, Serial Number 17478; UDI/DI N/A, System ID 519663INFINIA2, Serial Number 17023; UDI/DI N/A, System ID 905813INFINIA2, Serial Number 17052; UDI/DI N/A, System ID 705759HAWKEYE, Serial Number 17953; UDI/DI N/A, System ID 416864INFINIA1, Serial Number 17131; UDI/DI N/A, System ID 416864INFINIA2, Serial Number 17204; UDI/DI N/A, System ID 416469INHE4B, Serial Number 17543; UDI/DI N/A, System ID 450468INFINIA, Serial Number 17608; UDI/DI N/A, System ID 514252AINFINIA6, Serial Number 17161; UDI/DI N/A, System ID 514252AINFINIA2, Serial Number 17166; UDI/DI N/A, System ID 514252AINFINIA1, Serial Number 17287; UDI/DI N/A, System ID 514252AINFINIA4, Serial Number 17417; UDI/DI N/A, System ID 450654INF3, Serial Number 17622; UDI/DI N/A, System ID 514345AINFINA, Serial Number 17717; UDI/DI N/A, System ID 306655INFINIA3, Serial Number 16888; UDI/DI N/A, System ID 306655INFINIA5, Serial Number 17493; UDI/DI N/A, System ID 26329NM1, Serial Number 18010; UDI/DI N/A, System ID 082426110009, Serial Number 18219; UDI/DI N/A, System ID 082426040039, Serial Number 17369; UDI/DI N/A, System ID 082426040055, Serial Number 18532; UDI/DI N/A, System ID 082426040060, Serial Number 18585; UDI/DI N/A, System ID 082426040050, Serial Number 18366; UDI/DI N/A, System ID 082426190015, Serial Number 17663; UDI/DI N/A, System ID 082426200009, Serial Number 18313; UDI/DI N/A, System ID 082426100062, Serial Number 18599; UDI/DI N/A, System ID 082426020007, Serial Number 18577; UDI/DI N/A, System ID 082426200010, Serial Number 18581; UDI/DI N/A, System ID 082426130035, Serial Number 18445; UDI/DI N/A, System ID 082426130032, Serial Number 18478; UDI/DI N/A, System ID 082426160034, Serial Number 18123; UDI/DI N/A, System ID 082426180012, Serial Number 18574; UDI/DI N/A, System ID 082426180013, Serial Number 18512; UDI/DI N/A, System ID 082426090018, Serial Number 17658; UDI/DI N/A, System ID 082426210016, Serial Number 17719; UDI/DI N/A, System ID 082426200007, Serial Number 18233; UDI/DI N/A, System ID 082426100040, Serial Number 18590; UDI/DI N/A, System ID 082426100033, Serial Number 17405; UDI/DI N/A, System ID 082426100037, Serial Number 17776; UDI/DI N/A, System ID 82426230024, Serial Number 18584; UDI/DI N/A, System ID 2694427INF, Serial Number 17118; UDI/DI N/A, System ID 2646005INF, Serial Number 16886; UDI/DI N/A, System ID CY1015NM02, Serial Number 18185; UDI/DI N/A, System ID CS1021NM03, Serial Number 17797; UDI/DI N/A, System ID CS1318NM01, Serial Number 18037; UDI/DI N/A, System ID 600131NM05, Serial Number 17312; UDI/DI N/A, System ID DK1023NM03, Serial Number 17484; UDI/DI N/A, System ID DK1065NM05, Serial Number 17867; UDI/DI N/A, System ID NUC5178133HM6, Serial Number 18283; UDI/DI N/A, System ID S4160079, Serial Number 17244; UDI/DI N/A, System ID M4160449, Serial Number 16856; UDI/DI N/A, System ID M23084315, Serial Number 18069; UDI/DI N/A, System ID M4111216, Serial Number 16865; UDI/DI N/A, System ID Not Available, Serial Number 17540; UDI/DI N/A, System ID PC3964NU02, Serial Number 17506; UDI/DI N/A, System ID 740944NU01, Serial Number 18264; UDI/DI N/A, System ID HC6051NU03, Serial Number 18084; UDI/DI N/A, System ID 662608NU01, Serial Number 18014; UDI/DI N/A, System ID PC3970NU02, Serial Number 17172; UDI/DI N/A, System ID HC4480NU01, Serial Number 17100; UDI/DI N/A, System ID 876259NU01, Serial Number 17507; UDI/DI N/A, System ID 485520NU07, Serial Number 17718; UDI/DI N/A, System ID HC2252NU02, Serial Number 17757; UDI/DI N/A, System ID 493519NU02, Serial Number 18074; UDI/DI N/A, System ID CC1543NU01 or 441367NU01, Serial Number 16106; UDI/DI N/A, System ID 493519NU05, Serial Number 18387; UDI/DI N/A, System ID HC6051NU04, Serial Number 18352; UDI/DI N/A, System ID H2094NUC28, Serial Number 18296; UDI/DI N/A, System ID 828260015, Serial Number 17754; UDI/DI N/A, System ID 083026062000397, Serial Number 17102; UDI/DI N/A, System ID 083026006866397, Serial Number 16785; UDI/DI N/A, System ID 083026002101088, Serial Number 17467; UDI/DI N/A, System ID 083026002000469, Serial Number 17741; UDI/DI N/A, System ID 083026002100219, Serial Number 17736; UDI/DI N/A, System ID 083026822101249, Serial Number 17814; UDI/DI N/A, System ID 083026861008410, Serial Number 18009; UDI/DI N/A, System ID 083026202100886, Serial Number 16899; UDI/DI N/A, System ID 083026202100929, Serial Number 17745; UDI/DI N/A, System ID 083026062102318, Serial Number 17391; UDI/DI N/A, System ID 083026022002299, Serial Number 17686; UDI/DI N/A, System ID 083026022002291, Serial Number 17690; UDI/DI N/A, System ID 083026026463911, Serial Number 18257; UDI/DI N/A, System ID 83026600020711, Serial Number 18042; UDI/DI N/A, System ID 083055602816213, Serial Number 18564; UDI/DI N/A, System ID 083026608462741, Serial Number 17884; UDI/DI N/A, System ID IE1085MN05, Serial Number 17284; UDI/DI N/A, System ID IE1110MN01, Serial Number 16878; UDI/DI N/A, System ID IL1069NM11, Serial Number 16921; UDI/DI N/A, System ID IL1042NM09, Serial Number 17983; UDI/DI N/A, System ID IL1062NM26, Serial Number 17360; UDI/DI N/A, System ID IL1018NM08, Serial Number 17751; UDI/DI N/A, System ID IL1043NM20, Serial Number 17530; UDI/DI N/A, System ID IL1041NM18, Serial Number 16955; UDI/DI N/A, System ID IL1041NM29, Serial Number 18127; UDI/DI N/A, System ID IL1061NM17, Serial Number 18124; UDI/DI N/A, System ID A5197934, Serial Number 17733; UDI/DI N/A, System ID A5128755, Serial Number 17514; UDI/DI N/A, System ID A5129026, Serial Number 17055; UDI/DI N/A, System ID A5123523, Serial Number 17508; UDI/DI N/A, System ID B5174320, Serial Number 17685; UDI/DI N/A, System ID A5129959, Serial Number 17062; UDI/DI N/A, System ID F5119151, Serial Number 17788; UDI/DI N/A, System ID B5315345, Serial Number 17086; UDI/DI N/A, System ID B5119121, Serial Number 17810; UDI/DI N/A, System ID YN4259, Serial Number 18334; UDI/DI N/A, System ID YN4263, Serial Number 18503; UDI/DI N/A, System ID YN4265, Serial Number 18391; UDI/DI N/A, System ID YN4312, Serial Number 18479; UDI/DI N/A, System ID YN4253, Serial Number 18315; UDI/DI N/A, System ID YN4241, Serial Number 17865; UDI/DI N/A, System ID YN4239, Serial Number 17869; UDI/DI N/A, System ID YN4262, Serial Number 18462; UDI/DI N/A, System ID YN4257, Serial Number 18350; UDI/DI N/A, System ID YN4240, Serial Number 17541; UDI/DI N/A, System ID YN4233, Serial Number 17705; UDI/DI N/A, System ID YN4234, Serial Number 17747; UDI/DI N/A, System ID YN4218, Serial Number 17049; UDI/DI N/A, System ID YN4235, Serial Number 17738; UDI/DI N/A, System ID YN4288, Serial Number 17520; UDI/DI N/A, System ID YN4280, Serial Number 18506; UDI/DI N/A, System ID YN4300, Serial Number 17048; UDI/DI N/A, System ID YN4231, Serial Number 17696; UDI/DI N/A, System ID YN4232, Serial Number 17238; UDI/DI N/A, System ID YN4237, Serial Number 17824; UDI/DI N/A, System ID YN4923, Serial Number 17795; UDI/DI N/A, System ID YN4821, Serial Number 18147; UDI/DI N/A, System ID YN4822, Serial Number 18202; UDI/DI N/A, System ID YN4248, Serial Number 18086; UDI/DI N/A, System ID YN4261, Serial Number 18417; UDI/DI N/A, System ID YN4230, Serial Number 17439; UDI/DI N/A, System ID YN4244, Serial Number 17674; UDI/DI N/A, System ID YN4256, Serial Number 18360; UDI/DI N/A, System ID YN4264, Serial Number 18520; UDI/DI N/A, System ID YN4252, Serial Number 18235; UDI/DI N/A, System ID YN4222, Serial Number 17179; UDI/DI N/A, System ID YN4266, Serial Number 18504; UDI/DI N/A, System ID YN4254, Serial Number 18300; UDI/DI N/A, System ID YN4258, Serial Number 18351; UDI/DI N/A, System ID YN4224, Serial Number 17248; UDI/DI N/A, System ID YN4221, Serial Number 17338; UDI/DI N/A, System ID YN4236, Serial Number 17681; UDI/DI N/A, System ID YN4267, Serial Number 18505; UDI/DI N/A, System ID YN4242, Serial Number 17165; UDI/DI N/A, System ID YN4255, Serial Number 18085; UDI/DI N/A, System ID YN4251, Serial Number 18273; UDI/DI N/A, System ID YN4260, Serial Number 18182; UDI/DI N/A, System ID YN4243, Serial Number 18055; UDI/DI N/A, System ID YN4226, Serial Number 17406; UDI/DI N/A, System ID 0850260096, Serial Number 17090; UDI/DI N/A, System ID 0850260133, Serial Number 18396; UDI/DI N/A, System ID 0850260119, Serial Number 18112; UDI/DI N/A, System ID 0850260121, Serial Number 18129; UDI/DI N/A, System ID 850260108, Serial Number 17731; UDI/DI N/A, System ID 850260117, Serial Number 17956; UDI/DI N/A, System ID 850260098, Serial Number 17222; UDI/DI N/A, System ID 0850260111, Serial Number 17689; UDI/DI N/A, System ID LV4002NM02, Serial Number 18035; UDI/DI N/A, System ID LT4000MN03, Serial Number 18096; UDI/DI N/A, System ID 4716INFINIAHE4, Serial Number 17213; UDI/DI N/A, System ID 2750751INF, Serial Number 17636; UDI/DI N/A, System ID 36INF2753220, Serial Number 17470; UDI/DI N/A, System ID 2766055INFHE4, Serial Number 17370; UDI/DI N/A, System ID 2864298INF, Serial Number 17873; UDI/DI N/A, System ID NM18464, Serial Number 18464; UDI/DI N/A, System ID NMCR-18003, Serial Number 18323; UDI/DI N/A, System ID NM17697, Serial Number 17697; UDI/DI N/A, System ID NM18094, Serial Number 18094; UDI/DI N/A, System ID NA1027NM05, Serial Number 18386; UDI/DI N/A, System ID DHG0539, Serial Number 17231; UDI/DI N/A, System ID ZTP0133, Serial Number 17711; UDI/DI N/A, System ID EMM0131, Serial Number 17599; UDI/DI N/A, System ID NM18598, Serial Number 18598; UDI/DI N/A, System ID 0843260047, Serial Number 18210; UDI/DI N/A, System ID PL1143NM06, Serial Number 17306; UDI/DI N/A, System ID PER03520, Serial Number 18198; UDI/DI N/A, System ID PPR97306, Serial Number 17793; UDI/DI N/A, System ID PER12110, Serial Number 17918; UDI/DI N/A, System ID PER08009 , Serial Number 17611; UDI/DI N/A, System ID 787653INFINIA2, Serial Number 17289; UDI/DI N/A, System ID 787848INFINIA, Serial Number 18068; UDI/DI N/A, System ID RU8498NM01, Serial Number 18362; UDI/DI N/A, System ID RU3448NM01, Serial Number 18073; UDI/DI N/A, System ID RU2527NM03, Serial Number 17779; UDI/DI N/A, System ID RU3508NM01, Serial Number 17691; UDI/DI N/A, System ID RU3314NM01, Serial Number 17625; UDI/DI N/A, System ID RU3424NM01, Serial Number 17774; UDI/DI N/A, System ID RU2050NM01, Serial Number 17749; UDI/DI N/A, System ID RU1152NM02, Serial Number 17214; UDI/DI N/A, System ID ZA2246NM01, Serial Number 17486; UDI/DI N/A, System ID ZA2261NM01, Serial Number 17721; UDI/DI N/A, System ID ZA2212NM02, Serial Number 17158; UDI/DI N/A, System ID MEX68919, Serial Number 18019; UDI/DI N/A, System ID UP285A41, Serial Number 17679; UDI/DI N/A, System ID NPV15964, Serial Number 17917; UDI/DI N/A, System ID UE282648, Serial Number 17336; UDI/DI N/A, System ID FEE12426, Serial Number 17585; UDI/DI N/A, System ID AC001NU18, Serial Number 17429; UDI/DI N/A, System ID 849010NU01, Serial Number 17372; UDI/DI N/A, System ID 0853260105, Serial Number 18501; UDI/DI N/A, System ID 0853260069, Serial Number 18039; UDI/DI N/A, System ID 0853260103, Serial Number 18473; UDI/DI N/A, System ID 0853260100, Serial Number 18487; UDI/DI N/A, System ID 0853260032, Serial Number 16967; UDI/DI N/A, System ID 0853260129, Serial Number 18569; UDI/DI N/A, System ID 0853260036, Serial Number 17057; UDI/DI N/A, System ID 0856260032, Serial Number 18190; UDI/DI N/A, System ID 0856260037, Serial Number 18554; UDI/DI N/A, System ID 0856260038, Serial Number 18556; UDI/DI N/A, System ID 1573MI0001, Serial Number 18638; UDI/DI N/A, System ID 21011NUC01, Serial Number 16803; UDI/DI N/A, System ID 34017NUC02, Serial Number 17853; UDI/DI N/A, System ID 06014NUC02, Serial Number 17858; UDI/DI N/A, System ID 06051NUC04, Serial Number 17149; UDI/DI N/A, System ID 07021NUC01, Serial Number 17821; UDI/DI N/A, System ID 34329NUC01, Serial Number 18156; UDI/DI N/A, System ID 35003NUC05, Serial Number 18100; UDI/DI N/A, System ID 00373NUC01, Serial Number 18034; UDI/DI N/A, System ID 00002NUC02, Serial Number 17220; UDI/DI N/A, System ID 00105NUC03, Serial Number 18152; UDI/DI N/A, System ID 00487NUC04, Serial Number 17362; UDI/DI N/A, System ID 00433NUC09, Serial Number 17450; UDI/DI N/A, System ID 00257NUC15, Serial Number 17692; UDI/DI N/A, System ID 00393NUC06, Serial Number 18154; UDI/DI N/A, System ID 01344NUC01, Serial Number 18372; UDI/DI N/A, System ID 00383NUC03, Serial Number 17082; UDI/DI N/A, System ID 00067NUC01, Serial Number 18392; UDI/DI N/A, System ID 00136NUC08, Serial Number 18303; UDI/DI N/A, System ID 00240NUC05, Serial Number 17110; UDI/DI N/A, System ID 10448NUC04, Serial Number 18044; UDI/DI N/A, System ID 2723INFINIA, Serial Number 17395; UDI/DI N/A, System ID NM18455, Serial Number 18455; UDI/DI N/A, System ID 0859260011, Serial Number 18565; UDI/DI N/A, System ID 0859260013, Serial Number 18570. 6) H3000WD: UDI/DI N/A, System ID 415300IN, Serial Number 17067; UDI/DI N/A, System ID Not Available, Serial Number 18568; UDI/DI N/A, System ID 919684INF2, Serial Number 17346; UDI/DI N/A, System ID 512LRMCNM, Serial Number 18589; UDI/DI N/A, System ID 2769200, Serial Number 17407; UDI/DI N/A, System ID 082426110008, Serial Number 18149; UDI/DI N/A, System ID 082426110011, Serial Number 18613; UDI/DI N/A, System ID 082426040049, Serial Number 18440; UDI/DI N/A, System ID 082426040042, Serial Number 18080; UDI/DI N/A, System ID 082426040058, Serial Number 18563; UDI/DI N/A, System ID 082426040051, Serial Number 18593; UDI/DI N/A, System ID 082426040066, Serial Number 18618; UDI/DI N/A, System ID 082426040041, Serial Number 17639; UDI/DI N/A, System ID 082426190024, Serial Number 18567; UDI/DI N/A, System ID 082426020005, Serial Number 18259; UDI/DI N/A, System ID 082426160037, Serial Number 18538; UDI/DI N/A, System ID 082426140019, Serial Number 17587; UDI/DI N/A, System ID 082426140024, Serial Number 18483; UDI/DI N/A, System ID 082426110006, Serial Number 17237; UDI/DI N/A, System ID 082426070024, Serial Number 17934; UDI/DI N/A, System ID 082426200004, Serial Number 17163; UDI/DI N/A, System ID 082426180010, Serial Number 18361; UDI/DI N/A, System ID 082426090020, Serial Number 17880; UDI/DI N/A, System ID 082426150028, Serial Number 18528; UDI/DI N/A, System ID 082426050005, Serial Number 17457; UDI/DI N/A, System ID 082426160041, Serial Number 18616; UDI/DI N/A, System ID 082426100035, Serial Number 17414; UDI/DI N/A, System ID 082426100036, Serial Number 17727; UDI/DI N/A, System ID 082426100038, Serial Number 17728; UDI/DI N/A, System ID 082426290008, Serial Number 18266; UDI/DI N/A, System ID 082426210019, Serial Number 18429; UDI/DI N/A, System ID 082426180014, Serial Number 18600; UDI/DI N/A, System ID 082426080018, Serial Number 17839; UDI/DI N/A, System ID 082426150032, Serial Number 18595; UDI/DI N/A, System ID 082426230016, Serial Number 17999; UDI/DI N/A, System ID 82426150035, Serial Number 18615; UDI/DI N/A, System ID 082426150027, Serial Number 18592; UDI/DI N/A, System ID 082426150023, Serial Number 18306; UDI/DI N/A, System ID 082426150024, Serial Number 18218; UDI/DI N/A, System ID 082426160031, Serial Number 17833; UDI/DI N/A, System ID 082426160033, Serial Number 18049; UDI/DI N/A, System ID 082426160035, Serial Number 18187; UDI/DI N/A, System ID 082426160039, Serial Number 18410; UDI/DI N/A, System ID 082426160038, Serial Number 18535; UDI/DI N/A, System ID 082426240005, Serial Number 18596; UDI/DI N/A, System ID 082426240004, Serial Number 18591; UDI/DI N/A, System ID 082426170003, Serial Number 17978; UDI/DI N/A, System ID 082426070032, Serial Number 18523; UDI/DI N/A, System ID 082426090023, Serial Number 18398; UDI/DI N/A, System ID 082426070025, Serial Number 18056; UDI/DI N/A, System ID 082426070023, Serial Number 17850; UDI/DI N/A, System ID 082426010017, Serial Number 18572; UDI/DI N/A, System ID 082426090031, Serial Number 18539; UDI/DI N/A, System ID 082426090024, Serial Number 18234; UDI/DI N/A, System ID 082426090034, Serial Number 18537; UDI/DI N/A, System ID 082426090028, Serial Number 18286; UDI/DI N/A, System ID 082426090033, Serial Number 18484; UDI/DI N/A, System ID 082426090039, Serial Number 18609; UDI/DI N/A, System ID 082426090026, Serial Number 18375; UDI/DI N/A, System ID 082426090025, Serial Number 18545; UDI/DI N/A, System ID 082426190019, Serial Number 18582; UDI/DI N/A, System ID 082426190017, Serial Number 17819; UDI/DI N/A, System ID 082426190020, Serial Number 18485; UDI/DI N/A, System ID 082426090017, Serial Number 17154; UDI/DI N/A, System ID 082426060006, Serial Number 18544; UDI/DI N/A, System ID 082426120025, Serial Number 18587; UDI/DI N/A, System ID 082426120020, Serial Number 18381; UDI/DI N/A, System ID 082426120022, Serial Number 18454; UDI/DI N/A, System ID 082426120018, Serial Number 17800; UDI/DI N/A, System ID 82426030027, Serial Number 18586; UDI/DI N/A, System ID 082426030026, Serial Number 18543; UDI/DI N/A, System ID 082426150033, Serial Number 18606; UDI/DI N/A, System ID 082426230015, Serial Number 18099; UDI/DI N/A, System ID 082426100047, Serial Number 18434; UDI/DI N/A, System ID 082426100053, Serial Number 18541; UDI/DI N/A, System ID 082426310022, Serial Number 17966; UDI/DI N/A, System ID 082426310023, Serial Number 18536; UDI/DI N/A, System ID 082426100043, Serial Number 18087; UDI/DI N/A, System ID 082426100054, Serial Number 18540; UDI/DI N/A, System ID 082426100058, Serial Number 18573; UDI/DI N/A, System ID 082426100032, Serial Number 17310; UDI/DI N/A, System ID 082426100041, Serial Number 17920; UDI/DI N/A, System ID 082426130040, Serial Number 18497; UDI/DI N/A, System ID 082426130043, Serial Number 18620; UDI/DI N/A, System ID 082426130037, Serial Number 18426; UDI/DI N/A, System ID 082426100046, Serial Number 18421; UDI/DI N/A, System ID 082426230021, Serial Number 18542; UDI/DI N/A, System ID 082426230018, Serial Number 18368; UDI/DI N/A, System ID 082426230022, Serial Number 18546; UDI/DI N/A, System ID 082426230017, Serial Number 18224; UDI/DI N/A, System ID 082426310024, Serial Number 18518; UDI/DI N/A, System ID 082426270007, Serial Number 18158; UDI/DI N/A, System ID 082426250004, Serial Number 18597; UDI/DI N/A, System ID 082426250003, Serial Number 17236; UDI/DI N/A, System ID 082426140022, Serial Number 18195; UDI/DI N/A, System ID 082426140027, Serial Number 18533; UDI/DI N/A, System ID 082426140023, Serial Number 18347; UDI/DI N/A, System ID 082426140025, Serial Number 18547; UDI/DI N/A, System ID 082426140018, Serial Number 18132; UDI/DI N/A, System ID 083026002000938, Serial Number 17536; UDI/DI N/A, System ID 083026202100317, Serial Number 17138; UDI/DI N/A, System ID 083026842101817, Serial Number 17322; UDI/DI N/A, System ID YN4818, Serial Number 17466; UDI/DI N/A, System ID YN4219, Serial Number 17379; UDI/DI N/A, System ID YN4819, Serial Number 17656; UDI/DI N/A, System ID YN4249, Serial Number 18204; UDI/DI N/A, System ID YN4823, Serial Number 18534; UDI/DI N/A, System ID YN4910, Serial Number 18559; UDI/DI N/A, System ID YN4826, Serial Number 18578; UDI/DI N/A, System ID YN1641, Serial Number 17126; UDI/DI N/A, System ID YN4833, Serial Number 18269; UDI/DI N/A, System ID YN4227, Serial Number 17577; UDI/DI N/A, System ID YN4824, Serial Number 18526; UDI/DI N/A, System ID YN4827, Serial Number 18635; UDI/DI N/A, System ID YN4825, Serial Number 17740; UDI/DI N/A, System ID YN4900, Serial Number 17870; UDI/DI N/A, System ID PL1003NM03, Serial Number 17252; UDI/DI N/A, System ID 600092NM10, Serial Number 17889; UDI/DI N/A, System ID 787758INFINIA2, Serial Number 17107; UDI/DI N/A, System ID 0856260030, Serial Number 18071. 7) H3000WT: UDI/DI N/A, System ID HC4387NU02, Serial Number 17743; UDI/DI N/A, System ID HGV0130, Serial Number 17688. 8) H3000WW: UDI/DI N/A, System ID 205939INF, Serial Number 16277; UDI/DI N/A, System ID 256761INF, Serial Number 16554; UDI/DI N/A, System ID 501620INF, Serial Number 16200; UDI/DI N/A, System ID 623848NM2, Serial Number 16330; UDI/DI N/A, System ID 480301NM1, Serial Number 16331; UDI/DI N/A, System ID 626898INF1, Serial Number 16845; UDI/DI N/A, System ID 925INF, Serial Number 16374; UDI/DI N/A, System ID 818409INF1, Serial Number 16406; UDI/DI N/A, System ID 858554EDCINF, Serial Number 16429; UDI/DI N/A, System ID 925370IN, Serial Number 16981; UDI/DI N/A, System ID 209526IN, Serial Number 16676; UDI/DI N/A, System ID 714456INFINIA, Serial Number 16201; UDI/DI N/A, System ID 530225IN, Serial Number 16707; UDI/DI N/A, System ID 650367IN1, Serial Number 16558; UDI/DI N/A, System ID 707963IN, Serial Number 16883; UDI/DI N/A, System ID 831755IN1, Serial Number 16273; UDI/DI N/A, System ID 619229INF, Serial Number 16884; UDI/DI N/A, System ID 714953INFINIA, Serial Number 16892; UDI/DI N/A, System ID 719333IH, Serial Number 16600; UDI/DI N/A, System ID 719333IH, Serial Number 16652; UDI/DI N/A, System ID 203325INF, Serial Number 16436; UDI/DI N/A, System ID 727893INF, Serial Number 16623; UDI/DI N/A, System ID 706651NUC, Serial Number 16577; UDI/DI N/A, System ID 706494HNM, Serial Number 16647; UDI/DI N/A, System ID 404321INF, Serial Number 16445; UDI/DI N/A, System ID 706291HINM, Serial Number 16360; UDI/DI N/A, System ID 815741INF2, Serial Number 16620; UDI/DI N/A, System ID 815741INF1, Serial Number 16654; UDI/DI N/A, System ID 618436GSR02, Serial Number 16401; UDI/DI N/A, System ID 913676SMIM, Serial Number 16573; UDI/DI N/A, System ID 504838INFH, Serial Number 16341; UDI/DI N/A, System ID 207255INFINIA, Serial Number 16754; UDI/DI N/A, System ID 906337INF, Serial Number 16771; UDI/DI N/A, System ID 248338MLO01, Serial Number 16461; UDI/DI N/A, System ID 314525INF1, Serial Number 16222; UDI/DI N/A, System ID 228865HWK, Serial Number 16383; UDI/DI N/A, System ID 406238INF, Serial Number 16493; UDI/DI N/A, System ID 704384INFI4, Serial Number 16373; UDI/DI N/A, System ID 704384INFI4, Serial Number 16431; UDI/DI N/A, System ID 704384INH1, Serial Number 16414; UDI/DI N/A, System ID 704660HAWK, Serial Number 16714; UDI/DI N/A, System ID 701234INF2, Serial Number 16642; UDI/DI N/A, System ID 505262INF, Serial Number 16556; UDI/DI N/A, System ID 845794INFINIA, Serial Number 16597; UDI/DI N/A, System ID 419227I2, Serial Number 16633; UDI/DI N/A, System ID 937390INF1, Serial Number 16562; UDI/DI N/A, System ID 937374INF1, Serial Number 16835; UDI/DI N/A, System ID 918494INF1, Serial Number 16824; UDI/DI N/A, System ID 503435INF, Serial Number 16702; UDI/DI N/A, System ID 503561INF, Serial Number 16818; UDI/DI N/A, System ID 361985SNM, Serial Number 16769; UDI/DI N/A, System ID 915577NM1, Serial Number 16606; UDI/DI N/A, System ID 915521HNM1, Serial Number 16613; UDI/DI N/A, System ID 713242INF1, Serial Number 16605; UDI/DI N/A, System ID Not Available, Serial Number 16288; UDI/DI N/A, System ID 361572NM1, Serial Number 16602; UDI/DI N/A, System ID 435750INF2, Serial Number 16931; UDI/DI N/A, System ID 801314INF1, Serial Number 16424; UDI/DI N/A, System ID 801268INF1, Serial Number 16451; UDI/DI N/A, System ID 703698INF1, Serial Number 16599; UDI/DI N/A, System ID 757398INF1, Serial Number 16270; UDI/DI N/A, System ID 804323INF1, Serial Number 16496; UDI/DI N/A, System ID 509946INF, Serial Number 16329; UDI/DI N/A, System ID 414489INF, Serial Number 16894; UDI/DI N/A, System ID 608791INF, Serial Number 16709; UDI/DI N/A, System ID 608263INF2, Serial Number 16333; UDI/DI N/A, System ID 920794INF, Serial Number 16357; UDI/DI N/A, System ID 262334INF, Serial Number 16467; UDI/DI N/A, System ID AH5689NU04, Serial Number 16615; UDI/DI N/A, System ID AH5293NM04, Serial Number 16362; UDI/DI N/A, System ID 080026NU08, Serial Number 16386; UDI/DI N/A, System ID 210036NU06, Serial Number 16294; UDI/DI N/A, System ID 300013NU01, Serial Number 16535; UDI/DI N/A, System ID 403289NUC1, Serial Number 16956; UDI/DI N/A, System ID 604434INFINIA, Serial Number 16703; UDI/DI N/A, System ID 604520INFINIA3H, Serial Number 16252; UDI/DI N/A, System ID 604588INFINIA3H, Serial Number 16254; UDI/DI N/A, System ID 604588INFINIA4H, Serial Number 16278; UDI/DI N/A, System ID 604531INFINIAH, Serial Number 16638; UDI/DI N/A, System ID 506739INFINIA, Serial Number 16299; UDI/DI N/A, System ID 613969HAWKEYE, Serial Number 16488; UDI/DI N/A, System ID 519685INFINIA, Serial Number 16258; UDI/DI N/A, System ID 905813INFINIA, Serial Number 16607; UDI/DI N/A, System ID 905883HAWKEYE, Serial Number 16388; UDI/DI N/A, System ID 705674HAWKEYE, Serial Number 16327; UDI/DI N/A, System ID 514495INFINIA, Serial Number 16753; UDI/DI N/A, System ID 306766INF1, Serial Number 16501; UDI/DI N/A, System ID 306766INF2, Serial Number 16507; UDI/DI N/A, System ID 306655INFINIA, Serial Number 16399; UDI/DI N/A, System ID 082426040038, Serial Number 17022; UDI/DI N/A, System ID 082426150015, Serial Number 16347; UDI/DI N/A, System ID 082426180007, Serial Number 16302; UDI/DI N/A, System ID 082426190014, Serial Number 16717; UDI/DI N/A, System ID DK1026NM08, Serial Number 16521; UDI/DI N/A, System ID 2612588INF2H, Serial Number 16690; UDI/DI N/A, System ID FI1064MN01, Serial Number 16432; UDI/DI N/A, System ID FI1003MN06, Serial Number 16700; UDI/DI N/A, System ID M4479619, Serial Number 16199; UDI/DI N/A, System ID M9192701, Serial Number 16764; UDI/DI N/A, System ID GE1004NM01, Serial Number 16997; UDI/DI N/A, System ID 485520NU01, Serial Number 16618; UDI/DI N/A, System ID HC0863NU01, Serial Number 16590; UDI/DI N/A, System ID NM16490 , Serial Number 16490; UDI/DI N/A, System ID 0828260027, Serial Number 16328; UDI/DI N/A, System ID 083026822100665, Serial Number 16570; UDI/DI N/A, System ID 083026602100924, Serial Number 16325; UDI/DI N/A, System ID 083026602634522, Serial Number 16827; UDI/DI N/A, System ID 0835260007, Serial Number 16292; UDI/DI N/A, System ID IL1059NM07, Serial Number 16287; UDI/DI N/A, System ID A5367805, Serial Number 16598; UDI/DI N/A, System ID A5112411, Serial Number 16342; UDI/DI N/A, System ID A5306502, Serial Number 16202; UDI/DI N/A, System ID A5109666, Serial Number 16609; UDI/DI N/A, System ID A5153612, Serial Number 16444; UDI/DI N/A, System ID A224857307, Serial Number 16678; UDI/DI N/A, System ID YN1596, Serial Number 16637; UDI/DI N/A, System ID YN1590, Serial Number 16267; UDI/DI N/A, System ID YN1594, Serial Number 16549; UDI/DI N/A, System ID YN1601, Serial Number 16980; UDI/DI N/A, System ID YN1599, Serial Number 16757; UDI/DI N/A, System ID YN1592, Serial Number 16280; UDI/DI N/A, System ID MA1508NM01, Serial Number 16265; UDI/DI N/A, System ID AMS0338, Serial Number 16506; UDI/DI N/A, System ID LDD0431, Serial Number 16514; UDI/DI N/A, System ID ZWL0437, Serial Number 16352; UDI/DI N/A, System ID 301500885, Serial Number 16551; UDI/DI N/A, System ID 600042NM05, Serial Number 16958; UDI/DI N/A, System ID 787764INFINIA-1, Serial Number 16232; UDI/DI N/A, System ID 78NMIH2564713, Serial Number 16390; UDI/DI N/A, System ID RU2527NM02, Serial Number 16242; UDI/DI N/A, System ID RU2526NM01, Serial Number 16309; UDI/DI N/A, System ID ZA2678NM01, Serial Number 16546; UDI/DI N/A, System ID ZA2008NM04, Serial Number 16915; UDI/DI N/A, System ID ZA1806NM12, Serial Number 16681; UDI/DI N/A, System ID ZA1807NM11, Serial Number 16684; UDI/DI N/A, System ID ZA1808NM13, Serial Number 16679; UDI/DI N/A, System ID MPX99201, Serial Number 16544; UDI/DI N/A, System ID FPG86405, Serial Number 16595; UDI/DI N/A, System ID NP739716, Serial Number 16256; UDI/DI N/A, System ID A5136405DE, Serial Number 16338; UDI/DI N/A, System ID UK1110NM01, Serial Number 16644; UDI/DI N/A, System ID 10181NUC06, Serial Number 16729; UDI/DI N/A, System ID 21144NUC01, Serial Number 16906; UDI/DI N/A, System ID 00331NUC02, Serial Number 17038; UDI/DI N/A, System ID 10497NUC03, Serial Number 16402; UDI/DI N/A, System ID 00311NUC01, Serial Number 16417. 9) H3000WY: UDI/DI N/A, System ID 209831IN, Serial Number 16897; UDI/DI N/A, System ID 080004NU11, Serial Number 16282; UDI/DI N/A, System ID 082426160032, Serial Number 17083; UDI/DI N/A, System ID A5216823, Serial Number 16423; UDI/DI N/A, System ID A5224207, Serial Number 16204; UDI/DI N/A, System ID A5649008, Serial Number 17085; UDI/DI N/A, System ID YN1539, Serial Number 16289; UDI/DI N/A, System ID 600042NM06, Serial Number 16953. 10) H3000WZ: UDI/DI N/A, System ID 916781IN, Serial Number 16226; UDI/DI N/A, System ID 916703IN1, Serial Number 16891; UDI/DI N/A, System ID 415353IN, Serial Number 16409; UDI/DI N/A, System ID 402559INF2, Serial Number 16780; UDI/DI N/A, System ID 516622INFINIA, Serial Number 16348; UDI/DI N/A, System ID 214820INF2, Serial Number 16264; UDI/DI N/A, System ID 2555007, Serial Number 16350; UDI/DI N/A, System ID 519685INFINIA2, Serial Number 16481; UDI/DI N/A, System ID 082426150030, Serial Number 16552; UDI/DI N/A, System ID 082426030022, Serial Number 16438; UDI/DI N/A, System ID 082426180009, Serial Number 16495; UDI/DI N/A, System ID 082426150031, Serial Number 16815; UDI/DI N/A, System ID 082426150019, Serial Number 17079; UDI/DI N/A, System ID 082426150021, Serial Number 16813; UDI/DI N/A, System ID 082426150014, Serial Number 16485; UDI/DI N/A, System ID 082426120023, Serial Number 16349; UDI/DI N/A, System ID 082426120021, Serial Number 16572; UDI/DI N/A, System ID 082426120015, Serial Number 16996; UDI/DI N/A, System ID DK1026NM07, Serial Number 16578; UDI/DI N/A, System ID 427459NU02, Serial Number 16205; UDI/DI N/A, System ID A5547414, Serial Number 16831; UDI/DI N/A, System ID A5279301, Serial Number 16215; UDI/DI N/A, System ID A5114292, Serial Number 16361; UDI/DI N/A, System ID YN1744, Serial Number 16251; UDI/DI N/A, System ID 2660585INF, Serial Number 16961; UDI/DI N/A, System ID 2633201INF, Serial Number 16624; UDI/DI N/A, System ID 259170NU02, Serial Number 16248; UDI/DI N/A, System ID IE1564NM01, Serial Number 16565.
• Recalling Firm/ Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 4, Hayozma St; Tirat Carmel Israel
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
• FDA Determined Cause: Package design/selection
• Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/18/2024. The notice explained the safety issue and requested the following actions be taken: There are two populations potentially affected by this notification: NOTE: Specific serial numbers of the following affected systems: Infinia Nuclear Medicine Systems: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4; VG Nuclear Medicine systems: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH; Brivo NM 615; Discovery NM 630; Discovery NM/CT 670, Discovery NM/CT 670 ES, Discovery NM/CT 670 DR, Discovery NM/CT 670 PRO, Discovery NM/CT 670 CZT; Optima NM/CT 640. For Serial Numbers listed in Appendix A of this letter: GE HealthCare requests that you STOP USING the system until GE HealthCare has inspected and if necessary, corrected your system and provided you with a letter indicating the system can be returned to clinical use. GE HealthCare has determined that these systems could have previously been transported or relocated without proper detector support. For Serial Numbers listed in Appendix B of this letter: You can continue to use your system, as GE HealthCare has determined that these systems have not previously been transported or relocated without proper detector support. For Serial Numbers listed in either Appendix A or Appendix B of this letter: GE HealthCare requests that you DO NOT physically relocate or transport your system from its current location. If you need to move or transport your system, please email GE HealthCare at recall.40910@gehealthcare.com to receive specific instructions to follow before moving the system. When emailing this address, please provide the following information: " System serial number " Current system location " The reason for the move or transport, and subsequent destination Do not proceed with a physical relocation or transport of your system until you have received these instructions and taken the actions descri
• Quantity in Commerce: 845 units
• Distribution: Worldwide
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPS