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U.S. Department of Health and Human Services

Class 2 Device Recall AW Server

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 Class 2 Device Recall AW Serversee related information
Date Initiated by FirmSeptember 05, 2025
Date PostedOctober 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0068-2026
Recall Event ID 97657
510(K)NumberK081985 
Product Classification System, image processing, radiological - Product Code LLZ
ProductAW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Code Information UDI-DI 00840682102384 System IDs 907729AWS1 720238AW1 907ULMCCT 205934AWSRV 205975AWSRV 205971AWS 205510VAW 205815AWS2 UABMAWS1 749153GE3 UABMRPET 256593AW1 256265AWS4 256265AWS3 205481AWS1 251343AWS 251665MCIAWS 251316VAWS 251435AW5 251435AWSMARTSUB1 303584HP To be provided 251435AWSSMARTSUB1 256386AW1 205RCAWS 870423AWSMARTSUB1 870642AWS 718329SMART11 479314AWS1 479314AWS2 870207AW1 501686AWS31 501978AW1 501686AWSMARTSUB2 501552AW2 501202AWS1 501686AWSMARTSUB1 479338AWS 928773AWS 928214AWS 480256AWS 928757AWEN To be provided pacsaws01 To be provided 602344AWS 602651AWS 480342AWS 602277REVAW 480342AWSMARTSUB2 480342AWSMART1 480342AWSMART2 602344AWS1 602344SMARTAW 480342AWS2 602BUMC870 480342AWSMARTSUB3 928445AW1 06A6A668-AW-AWS_PRIMARY 844823AW1 844823AW 928283AWSMARTSUB1 520STJAWS 818RIAWSVR 661CHAWS 661KMCAWS 13123 13767 650696AWS To be provided 530UCVETAWSERV To be provided 760633HDCT To be provided 714FVAWSERVER 714FVDISC 510792AWH 559326AWS1 714447AWS AVHHFCTAW1 858657AWSMARTSUB2 858626AWS32 858824AWSMARTSUB2 858824SMARTSUB1 To be provided 909558SMART 805737AW2 562826AW46 9694 9693 323361AWSMARTSUB1 13256B To be provided 13526B 559353AW1 949367AWS 323BEVAWS 951704AWS 949764AWS 949764SMARTAW 510534AWS 510869AWSERV 510752AWS 916SUTABAWS 510437AWDL360 5496962AW11 510869APEX 760940AWS32 760940APEX 714771AWSRV 714456AWSMART 714456AW 650725AWS10 650725AWS30 650725AWSVM1 650725AWSVM2 650725AWSVM3 808341AW2 760446AWS 949278AW2 916SUTAWS 916SUTAWS2 916UCDAWS To be provided 858966SERVER 619532SERVER 9907 858657AWS32 858939EHLAWS 858626EHLAWS 858805AWSVM01 415600AWSERVER 415833AWSF 415476AWV 415MBCREV1 UCSFAWS4 UCSFAWS3 650725AWS20 408GSHOGEAW 408259EDCT 510784AWSERVER 9200 13195B 13196B 650696PET 805AWVM 310264AWS SHCGEAWSVM2 To be provided 818881AWSVR 805434AWS AWSHT1 310222HPAW 310823EHL1 310423EHL2 310423EHL1 To be provided 818782AWS1 To be provided 818676AW4 310423AWS 310423AWS2 To be provided 970544AWS 720848AWSRV 719365AWS DHAWSERV1 MCAAWSERV 303602AWS1 303DHREVCT 970945AWL03 970945VAW 307FRMIPCT4 719955REVO1 303603AWSRV 720321AWS1 303730AW 719584VPSW 203384AWSERVER 203739AWS 860679AWS 860679AWSSCT To be provided 860JRAWS 860972AWSMARTSUB2 203694AWSMARTSUB1 203694RTCT16 203694CTREV 860344CTFR1AW 860358AW1 To be provided 860224AWSVR1 860224EDAWSSCT 860224APEXAWSSCT 203737AWSVR 203276AWS1 203380AW1 860496AW02 203261AWS 860456APEXAWSSCT 202715AWS 202476AWS 202877AWS32 202745CT1 To be provided 302744AW 302744AWSMART 302645AWS1 302733AWSERVERL02 302733AWSMARTSUB2 To be provided 302645AWS DUPONTPETMRAW 732996AW1 727398AWS2 727398AWS 561955AWS1 561955SMARTSUBAWS1 561955AW2 954450AWS 561955SMARTSUBEVO1 561736AWS To be provided BRANDONAWS To be provided 352799AWLOW 352597AWS2 813635MPAWS 321799CTT03 321799AWS 314868AWS1 386HAWSERVER2 AM1436W320_DUP To be provided RADIOLOGY20072529AWS 772LMCAWS 850863AW1 352376AW 333SERV MEMAWSERVER MEMAWS 786243AWS1 BAYONETPTAWS To be provided 904202VAWS 904953AWS2 904953AWS 904202AWS 904953AWS3 904244AWS1 904ASHCHIVAWS 904996VAWS AM13D0X149_DUP 561747AW49 OSCAWSERVER 407PCSERVER 863577MRAW WATSONAWS2 321HFSERV To be provided 305575AWS 305596AWS 786596AWS 786596AWS1 305223AWS 305575REVO 786596WKSMART To be provided To be provided To be provided To be provided To be provided HCIT5218773AWS 305535AWSR NCHAWSERV NCHAWSERV2 239NHAWSERV USONCAWSRV 352816AW 850383AWE2 850383AWE1 OVAWSERVER 561346AW 386TLSERVER 954844AWSMARTSUB1 850494CTAWSER 941883AWSERV 772335AWV AM141C095 To be provided 904819AWS 407321AWL02 FAWCETTAWS LARKINAWS32 305284EVO To be provided 850431AWSERVER 813635AWSRV MACDILLAWS BAYCAREAWS1 BAYCAREAWS2 MOFFITTAWS2 954767AWE2 954767AWE1 AM15P4F42_DUP HLEEMOFF20867329 561969AWS1 404616AWLTSERVER 770903AW3 404686AWSMART 404686REV80AWS 404616AWSMART2 404616REV_ES_AWEHL 404616AWS 404616AWSMARTSUB2 404616CASSAPEX2EHLAWS 404616CASSAPEX To be provided 404686APEX_EHL_AWS 404686REV_80_AWS 706774AWSER 912466OAW 912466AWS 770812HP 706544MAAWS 706787AWSERV 706787PCT To be provided 770219AW1 770535REV 404712AWSERVER2 478633AWSMARTSUB1 478633UWAASTDV2 478633UWAASTDV 912350CTREV2AW 229228AWS43 229228AWCL4 229353AWS To be provided 808YMAWHT 808522AWHT 808432AWHT2 808432AWSMARTSUB1 808522AWS1 808522AWHT1 808233AWSMARTSUB1 808KMAPCT 808432REV 808433AWHT 515282CTAW 319338AWSXL 641428AWS3 712737AWSMARTSUB2 319272AWSERVA 208422REVAW1 208954AWS 208205AW1 630264AWS1 847381AW 630268AWSRV 1000005354AWS 1000005358 630266EHLAW 312864PAWSW 773296AWSRV 773292AWSRV 312942AWSRV 773665AWS 773702AWS 312454SMART 312996CTRV2EHLAWS 312996AWS1 312864AWS 773962AWS 312996CTASCAWS AM13DKD98 773665D710 815756AW To be provided 630275AWSRV 847437AWS 847316AWS 1000003355EHLAWS 708202AW1 70824SMARTAWS 815741AWS 630364AWS1 630268AWSVIR 618998AWS1 708216AWSRV 708216NM870 To be provided 618244AWS1 630527AWS 815300AWSVR 309454AWS1 708425AWSRV 708425AW32 708425CTRV2EHLAWS 708383AWS AM15A0C2292_DUP 708747DIS610 1000005331 708274AWS 847723AWSRV 847723AWS 309691PSERV 1000004500 1000000098 1000003733 561589AW 309683AWS1 309655AWS 309683AWS3 1000005353EHL 1000000010AWS 309672REV1 309691HD750 1000005502 To be provided To be provided 1000003732_AWS 217223AWS1 815226AWSR 815971AWS 779696AW1 1000004006AWS 847305AWS 217528AWS 217383AWS1 217337AWS1 To be provided 630824AWSMARTSUB1 765298AWS1 765298AWS2 260665AWSERV 812934AW2 574546MAXCTNANO MSKAWCUSTOM50 812485SERVAW 812450SERVAW 260266AWSERV 574364AWS 317887AWSERVER 317621AWS1 574204AWS 765747AWS1 812471PETCT To be provided 574647AWS 574647REVCT1SSAW 574647AWSUB 574267AWS1 913588AWS 913588AWS2 913588NREVAWS 913588APEX1AWS To be provided 913588APEX2AWS 4514429AW11_DUP 913676SAWSERVER 913588WWAWS 316262AWS To be provided 270745AWSRV 502875AW 859233AWS 859276AWL02 859313AWL03 502897IGS740AW1 502287PETAW 270767AWSMARTSUB2 270752AWSMARTSUB4 270767CTREV 270444AWS1 270575AWS1 859879DIAG 859737AW3 225755XR656 985NOAWSERV To be provided 504842AWSERV1 504842ERCT 318395AWS1 504349AWS 504347AWTIER1 504988AWS1 318410AW4 318214AWSMARTSUB1 318214SMARTSUB1 504529CTAW 504TOURMRAW 504988AW2 337948AW 985446HPAW 985493PET1 0850210870AS1 617726AWSCTMR 6177263DAWS 617414SERV1 617754AWSMARTSUB3 617754AWSMARTSUB2 857880AW 617754SMARTSUB2 To be provided To be provided To be provided To be provided 617665SERV1 617665AWSMARTSUB1 617665AWVEN1 516252AWSMART 617381AWSMART1 STEWARDAWSRVR 508457AWS1 508971AWS1 978466AWSVR1 781306AWSMARTSUB1 781213UWAASTDV 781453AWSMARTSUB1 41344716K 978741AWS1 978741AWSMARTSUB1 To be provided 978741VIRAW1 781624AW 781624AWSMART1 781624AWSMARTSUB1 518243AW45 781624AWSMARTSUB2 413748AW 413794AW2 413748AASW 413568AWSMART 413794AW1 413748PVSW-AWSVMTEST 508334AWTIER 410333AWS To be provided 443643CTAW 443643SMARTSUB1 443643AWSMARTSUB2 301496AWS1 410822AWS 240964AW 412607AWS1 412607AW1 240637REVEVOAW 808341AW1 410337AWSMARTSUB1 207621AWL03 207563AWS1 207795AWS 207795HPD1 207795AWSMARTSUB1 207255AW 207662AWHTS 207885REVCT5AWS 207662REVCT4AWS 207662REVCT3AWS 734936AWSRVM 734936AWSRVR3 UMREVCT2 To be provided 734844AWS1 517353AWS 810732AWS 810606ASW1 616391AWS 616AWS 616685D870CZT 616392AWS 616546AWS1 906486AW 269341AW1 269341AWS1 269341AWS2 517364AWS To be provided 269789AWS 248465AWS 248849AWS2 248898AWS 989583VAWS 989907AWL To be provided 248849AWS 231213AWS 231935AWSCT 586576AWS 586573VMS 734763AWS1 763792AWS 507385AWS1 507794EHLAWS 612725PETAW 507284AWS2 507284AWS1 NM1069915 WS278814 WS529288 314344HORAWSRVR To be provided 816698SMARTSUB2 816691AWSERVER 816932AWS 816276PRIAWS 816276AWS 816282NM870 573686ASVR 816271AWSMARTSUB2 816271AWSMART1 816271AWSMART2 816271AW 314251MMR5AW1 3148652AWSMARTSUB2 314251AWS4 314865RECT 417269AWSMART1 417269AWSMARTSUB2 417820AWSMARTSUB1 901227AWS1 901227AWS2 228GPAWSRV 228575CTAWVM 601288AW1 601264EVOAWS 601264AWS 601288AWV3X To be provided 601968AWS1 601982SERV 601982AWS1 333332AW1 MSKAWCUSTOM35 MSKAWCUSTOM34 662841AWSVR 662337AWS1 406731AW1 406455AWS1 406455CTREV 406329AWSRVR 336884AWS1 828213AWSVR 828257AW1 910721CTMAX 828262AWS 910450AW 704783AWS 704597AW1 To be provided To be provided 828894SMARTSUB1 828894AWSMARTSUB1 704403CT1SSAW 704801APEXAWS 910892GLDSLAW 919684AWSERH 919684AWSERL To be provided 704834AWS To be provided 336832APEXAWS 252744AWSERV 828696AWS 828681PRAWS 828681AWSMARTSUB2 828681CTSMARTSUB To be provided 336884APEXAW 704612AWSMARTSUB1 336846REVOAW 704403AWSMARTSUB2 704403SMARTSUB1 336564CT1 828757REV1 980993AWSMARTSUB1 980993SMARTSUB1 704355AWS 336719REV1 336719CT3 CEAWSERVER 910715AWS1 252908AW 704512APEX1AWSMART 919938AW1 910642AW1 910667AWSMARTSUB1 910667AW2 910772AW2 336713AWS1 336716AW 336397CT11 336765AW 605328AWS AM137HD87 701857AWS 308537AWS2 308865PETAWS2 308455REVSMARTNANO 308865PETMI 402481AWS1 402481AWS2 402484AWS1 To be provided To be provided To be provided 402559AWS1 603650AWS1 603629AWS 603668AW 603668AWSMARTSUB1 603629CT660 603526AWSMARTSUB1 603356AWS1 703689AWS To be provided 732840AWS 856886APEXAWSMART 609463AW532 856488AWSMARTSUB1 609922AWSMARTSUB1 973676AWS 732321AWS 732294LAWS 609652AWS 609914AWS1 609584AWS 732739AWS 201635MSKCCVM To be provided 732775AWS 973971AWS2 973971AW2 973971AW11 973971ASCEND To be provided To be provided 732776AWS1 To be provided 973972AWS 973926AWS 973877AWS 973972AWV 4211061AW41 609380AWS AM14EGX46_DUP 732360AWS 973754AWS 609537AW1 973831AWSR 201634AW 201447AWSERV2 908522AWS1 732557CTAW 973754AWSMARTSUB1 973534AWSSMART 505609AWS SJRM20570373 575556AW1 575627AWS 505368AWS 702616AW 702961AWS 702724AWS 702724PET 518262AWSMARTSUB2 518373AWS 518262AW1 518262AWSMART1 518262SMARTSUB4 518626AWS1 51262AWSMARTSUB4 518262AWSMART3 518842AWS 718918AWS 914349AWS13 BLH20533405 BLH20081761 718918AWSMART 718920SMARTSU1 718904AWSMART1 718904AWVM 914349AWSMARTSUB1 718519SMARTAWS 718960AWS To be provided To be provided To be provided 718920AW2 914787AWS 914787EVO To be provided To be provided KCAWSERVER 718567AWS 718250AWSVIRT 718780APEXSMARTAW 718238DISCIQ 718240EDCT 718836AWS To be provided 718250AWS 716845AWMR42 716845REVOCT 516877AW11 518292AW 585755AWS3 631638AWSMART 631CMKTEMPO 914737AWS1 718334AWSERVER ELMVIRTAWS 607776PRISTINA4 914457AWSMARTSUB1 To be provided 516674AWSMARTSUB1 518773AWS 631670AWS 516563AWS 570529AW1 718206AWS 718206AWSVIRT 607WMCAWS1 845334AWS 516622AWS To be provided 646962AWSMARTSUB2 646962AWSMARTSUB1 516622SMARTSUBAW1 631548AWS 631291APEXSS 607535REVCT 914666AW3 914666AWSMARTSUB1 914666REV 718920AWSMARTSUB1 718920SMARTSUB1 EHAW2SERVER LIJ066505AWS 516NYCBAWSMARTSUB2 LIJ071291AWS NSLI21213406 NSLI21213404 NSLI21213403 NSLI21213402 NSLI21213401 NSLI21213400 NSLI21213399 212241AWSERVER 212562AWSERVER 212369AWSERVER MSKAWSDL580 NYPHLTSERVER MSKAWCUSTOM30 MSKAWCUSTOM29 MSKAWCUSTOM28 MSKAWCUSTOM27 MSKAWCUSTOM26 MSKAWCUSTOM22 CORAWRSH HSSAWSERVER NYPHAWSVR05 NYPHAWSVR04 NYPHAWSERVER2 NYPHAWSERVER 212305MH3SMART 212639AWS1 BELVIRTAWS 568185AWSMARTSUB1 NYPHJOSUB1AW NYPHDHKSUB1AW 212305MH3SMARTAW CHONY3SMARTAW 212312AWSMART HSSM3CT750A MSK68IR3ANGIO To be provided MSKAWSCUSTOM31 CHONY3CTAWSMARTSUB1 paviradgeaw8 paviradgeaw7 paviradgeaw6 paviradgeaw5 paviradgeaw4 paviradgeaw3 paviradgeaw2 paviradgeaw1 AM126TR857O 212241AWVCT MSKAWCUSTOM33 516632AWS2 516632SMART1 To be provided 516719AWSMART 631751AWS 518926AW 631PBAWS 516734AWSMARTSUB1 To be provided 585275AWS 585922AWS 585275AWS1 To be provided 516705AWSMARTSUB1 518897AW 212305AWS 518243AWSMART 518243AW46 516266SMARTSUBAW1 631726AWS To be provided 718226VZAWS 718226AWSMART1 718226AWSMARTVZ 631444AWS 845368AWS30 315464AWS2 802342AWSMART1 802342AWSMART 315464AWSMARTSUB1 212305AWSMARTSUB2 315473AWS 607865REVAW 914682AWS MSKAWCUSTOM54 MSKAWCUSTOM53 MSKAWCUSTOM52 MSKAWCUSTOM51 MSKAWCUSTOM39 MSKAWCUSTOM38 516705AWSMART1 914681WPHAWS 914681AWS 212608AW 914681AWSVM 914681AWS1 212608CT 716688AWS 716597REV1 914666AWSMARTREV1 330792AWS 216293AWS2 216293AWSMART 330729SMART2AWS 330729AWS1 740439AWS1 513584AWS1 859371MFAWS 513584AWS 513569AW11 513636AWS To be provided To be provided 216791AWSERV 614293AWS 614293DAWS 419526AWSERV 614DHWAWS 614RMHSSAW2 614RMHSSAW1 614GMCER2AWS 614HOBRT2 614CANASAWS 937208AWS1 740GDYEVOAWS DMHAPEX1AWS To be provided DMHEVO2SSAW 513290AW1 513803AWS2 419227AWSMARTSUB1 419526AWSMARTSUB2 419526SMART3AWS 614RMHAWS 740383REVOAWS 740633AWS To be provided To be provided 740348UWAASTDV 419394AWS 419291AWSMARTSUB2 419291AWSMARTSUB1 419578AWSMARTSUB1 330841AWS1 To be provided 614WMCERAWS 330480AWSMART1 330480AWSMARTSUB3 330481AWSMARTSUB1 330480AWSSMARTSUB2 580559APEX160 580559APEX160AWS 918577AWS1 405773AWS1 918758AWSMARTSUB1 918838AWSERVER 918494SERVER 918233AWSERVER 918640AWSMARTSUB1 918505IGSAW 541789AWS2 503418PETMRAW 503216AW1 541MCAWSVR 610402AWSERVER2 484526AW 724773AWS1 484526APEXAWS 484526ASCENDAWS To be provided 717262LTAWS 570645AWS 272212EHLAWS 610954AWSERVER 484503REVAW1 484822AWSMARTSUB To be provided 814877AWHT 814838PVSW1 814868AWSMARTSUB1 724450AWS 724357AW 635217GE3 866785AWS 215707AWSERVER 215537SERVER 215CHOPAW2 215503AWSERVER 215728AWS1 215728FCCCREV 412623AWSRV3 412942AWSERV 412802AWS3 412802AWS2 412802AWS4 412942AWHT 412802AWS6 412802AWS1 412942AWS1 To be provided To be provided To be provided To be provided To be provided To be provided To be provided 412802AWS 610327AWSERVER 267985NANO 215453AWLT 814676AWSERVER 814231AW3 610869AWSERVER 570552AWS 570842AWSERVER 570824CT To be provided 412802AWS5 717855HTAWS AM15RJE119_DUP 401444HPD1 401444AWSERV 401782AWLT 401348CTAWS1 864512APEX1AW 843789DISCAW 843789DISC 0004375151 To be provided 843347AW1 864255AWS 864725AW2 843692AWSERVER 910269AWS12 864560AWS1 843209AWS1 803774AWS 803936AWS 803791AW3 605322AWVS 605328AWH 605333SMARTAWS 605333AWSMARTSUB2 To be provided 423844SERVER 423708PET 931528CT 615435AWSBJ 731541AWS1 731541CTAWS 731541AWS4 423433FCTAWSEHL 865584AWS 865588CT1 865977AWSERV 916EXPOAWS 901522AWS 901595AWS 901523AWS 901516AW346 901287AWS1 AM13DLV175 TBD 615349AWSERV 615327AWS 615284AWSERV 615327AWS2 615AWSERV 706291SERV 615322AWS3 615463AWSERV 615222REV1 To be provided To be provided 325670AWS 325670AWS3 817465AWSR 512324AW 512TRAVISAWS 512UTAWS 979MGAWS 832325AWS1 979SJAWS 979KSAWS 936539PRAWS 361RISTAWS 361761AWS2 281477AWS1 281477AWS2 214857VAAWS1 214645PTMIAW 214345AW1 469HPAWS 214645AW1 214820870NM 915544AWSMARTSUB1 915532HPTIER 210BAMCAWS32 956389AW 713792AWS 713442AWS2 713563AWS 713HCAHAWS 713566AWL02 713790AW2 MHTMCAWS2 MHTMCAWS 713790AW1 713791AW 281929AWS 713790AWS 713442AWS7 713442AWS8 713ACT48SAWS 713ACT49SAWS 713486AWCAW 713441AWSMARTSUB1 832522AWS1 713790AWS2 713791DISC AM12X6P114_DUP To be provided To be provided To be provided To be provided To be provided To be provided To be provided To be provided To be provided To be provided To be provided To be provided To be provided To be provided 414559AWSMART1 AM13YTC307 281319AWS1 To be provided 281737AWSMARTSUB1 432221AW 713790AWS1 713790APEX1_NANO 903243AW1 463814AW2 601310AWSMARTSUB2 USONCAWS2 210450AWS 210351AWS 210575AW41A1 210617REVOAW 210MHSWSMARTSUB2 210MHSSMARTSUB1 210MHSSMARTSUB2 210575AW1 713442AWS5 713442AWS3 254965AWS1 713442AWS11 210219AWSMART 254SWAW2 936270AWSMARTSUB1 936270AWS 830278AW 361572SSASW 361572SSASW-AWN 361573UWAAVMSW 254TSICT 713442AWS6 801855AMX4 435716AWSVM 801314AWS1 801507REV 801507CTSMARTAW 801479AW6 AM13J3U3 435658AWS1 435658REV1 435637SERVER CUMC15111209 801357AWS1 801357SMART1AW 801718AWS1 435251SMART1 435251NM 801581D710AWS 801662AWS 801662AWS1 385531CT2SMAWS 801268AWS1 To be provided 801501AWS1 703504AWS1 703664AWREV1 703849AW41 703558AWSRT 434SMJHS1 804281AWS 703698AWS 703391AWS 703858AWS 703698AWS2 703391AWS1 703698SMARTSUBAW1 FH120609295AW2 FH120609295AW1 703776AMX3 703776AWS1 434315AWS 571231AWS1 757722AWSERVER To be provided 703369AWSL 276666AWSER 804594AWS3 757388SERVER1 To be provided 804SRMCAWS 703648AWSL 703648AWSH 571367AWSH 804VCUPETAWS 804281AWS3 501387AW 5156567PT11 804289CT660 AM14B89292_DUP AM16KDW1458_DUP To be provided 540776AWS2 703776AWS 757455AW1 540536AWSL 540536AWS 703523AWS 802238CT1 802775CTAW 802775AWSMARTSUB1 To be provided 802775UWAASTDV 425688SMARTSUBAW To be provided To be provided To be provided To be provided To be provided To be provided 425261AWS 425899OPTSMARTAW 206545EESW 206215AWS 206598AWSVR 206987AWS 206598AWSVR2 206668AWSMARTSUB1 206277AWS2 425258AWSMARTSUB 206598AWSMARTSUB3 206598AWSMARTSUB4 206598AWSMARTSUB2 206598VAWS 206598AWSMARTSUB1 206368AWSMARTSUB2 888825AW1 253968AWS 253968AWS1 MAMC2NM870 To be provided 360SWSERVER 920454AWS1 920738AWSMARTSUB1 920361AWS1 608930ASCENDCT 414326AWSERV2 608775AWSRVR1 To be provided 801581MIAWS 608263AWSERV 262415CT520 414326CSMAWS 414266AWSERV2 414805AWSERV To be provided 920729AWSMARTSUB1 111111111 262569AWSMART 262656AWSERV 262656AWSERV1 681342PCTAWS1 304526SMAWSERV INVIVOPET6 304264AWS 304293MR3TAW To be provided To be provided 307444AWSMART 307777AWLOW AL4093AW01 AL4004AW05 276954478 DZ1009AW05 DZ1004AW09 DZ3053AW03 DZ1863AW03 DZ2684AW02 DZ1335AW01 DZ1038AW01 DZ1045AW07 DZ1045AW06 DZ2673AW05 DZ2673AW04 DZ1062AW03 DZ4291AW02 DZ5026AW01 DZ1015AW03 DZ4258AW02 DZ1070AW03 DZ4016AW01 DZ1193AW06 DZ4609AW01 DZ1090AW06 DZ3723AW01 DZ3724AW01 DZ4149AW01 DZ1061AW07 DZ3972AW02 DZ3445AW02 DZ3635AW01 DZ2092AW02 DZ1128AW05 DZ1856AW06 DZ1027AW06 DZ4619AW03 DZ2416AW01 DZ3053AW02 DZ2773AW02 DZ4227AW01 DZ3805AW01 DZ1908AW05 DZ3343AW02 DZ3953AW01 DZ5076AW01 DZ5054AW01 DZ5038AW02 DZ1255AW03 DZ1235AW02 DZ3610AW02 DZ1638AW09 DZ1147AW02 HCIT4308951AWS MR7949ARAWS2 MR7949ARAWS1 HCIT4706078AWS HCIT4731149AWS HCIT4986733AWS HCIT1536851AWS HCIT4919173AWS HCIT4936778AWS HCIT4825134AWS HCIT4890853AWS HCIT4430774AWS HCIT4430774AWS3 HCIT4430774AWS2 HCIT4430774AWS1 HCIT4532706AWS3 83153230682 832AW000002CT1 0910492056 AUAWX23204492 83199163254 834AWS000176CT1 83179605857 83151839074 83093285391 83098956691 AUAWX24490813 0910492069 83162992905 83162511620 83163140157 83095978437 832AW000002MI1 AUAWX24438408 AUAWX25000297 10385790 832AW000162CT2 83200117961 83170652378 83154708501 83174466616 83179605493 832CT000044AWVS AUAWX25299969 832AW000163CT3 83188558879 0910492057 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905527AWS1 905522AWS2 905522EHLAWS 780532AWS 250318AW1 250979AWS1 250862AWS 250712EHL1AWS1 250979DMI1 613258VMAWS 902678AWS 613548AWSHT1 418665AWS 604514APEX1EHLAW1 450662AWS 519322AWS1 519322AWS 519663AWS 519646AWS 905883XELSV 506857AW78 To be provided 514376AWS 514934BAWS 514934AWS 514340D870C 514252D870ASCT 514866AWS1 613354AWLT 705647AWS 905895AWS 604988AWS E416249AWS1 905845REVCTEHLAWS 905845AWS 519941AWS1 705327AWS 905433AWS 613761AWS 705746AWS 403627SMSUBAW 306765AWS1 250565AWS To be provided 403343APEX1AW1 To be provided 306766AWS3 306766RCT1 418862AWS2 418862AWS To be provided 819324AWS 519464AWS 306966AWS1 306931AWS 416284AWS3 204785AWS 807737AWS 250565AWN2 4726798AW21 250565AWN1 250565AWN3 450746AWS 450746D870 905684AWS 506648AWS1 506648AWS 709737AWS 204326AWS 519272AWS 519245AWS 705522AWS 705674NM870 604582AWS 604588AWN1 604582APEX1EHLAW1 604930APEXRT1AW1 604588LSVR 306778AWS 902567AWS 450654AWS 450581AWS 416813AWS 416530VAWS 416581AWS 416581AWSMARTSUB2 416530VAWS2 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A5108735 A53155114 A5624155 A5124164 A5147207 A5158822 A51299178 10931328 A5292331 D5114918 11960500 A5483707 08903131 B5367328 A5145935 A54013128 D5111652 A5820147 A5820154 A5320165 B5320436 A5320426 C5126836 A5359622 A5820185 A5697726 B5320127 B5140642 A53796127 09553467 09657915 09772554 D5820808 11960458 A5600103 A5348014 A670060225 A5362308 C5346712 D5109654 A5129131 A255888103 A173433245 AWS32IOV ITIRM1AWS 08980221 AW32CAMPO A5719870 A5163331 A5163335 A23086008 A139476003 A258001702 09435697 09692300 B5300713 A127292416 11960448 11960447 08953461 A5189370 A5366325 10729497 06B6B374-AW-AWS_PRIMARY C5210510 09599964 13634472 C5323539 C5323542 A51142156 B51142165 A51142154 10198977 08915985 A5367323 A159405610 A5229915 A5730913 C5367808 10041154 A5115183 11960466 A6340103 A5300208 09943706 5314024A 14490653 A224857357 A5139657 A51581134 A51581129 A5269719 A5391009 A5196822 A5118556 A5196830 A256767602 A58091SS01 A5332121 A5332120 09672472 A5379318 B5603950 A5902010 A422328501 A5138133 A5690010 A5678733 A5333083 A5743104 A51529176 C5358903 A56183195 A56183193 A5144931 C5618323 A5721915 A139569305 A5688113 A5721922 A53330149 ROMAIDI A57219 sfnaws01 09641114 5293842A2 5293842A1 09052350 12764113 11961146 pacsaw01 pacssen02 pacssen01 11388609 slp-pacsaw02 slp-pacsaw01 A5691235 B5320627 B5320634 B5320633 A5640203 10249097 12952416 A5383110 A5155169 A5138520 B5332015 E5373404 A5261115 A5261111 A196626506 A196626503 12123856 A5238826 A5238830 A665033302 A5725520 11960962 A51026120 A51026133 10729505 A5267112 12918968 A5141735 A5402121 A5402119 C5343508 A5103544 A757633202 A5189735 A5128420 B5580616 A5389825 A99263314 B5580651 09698520 09993033 09897949VM A5634730 A51043 SRV-AWS02 A5739715 A5407812 A5164528 12242336 A5105147 A6215807 A378428333 B5120746 09970636 A5208214 A51014122 A51014154 09647489 A57198 A5635622 B5146041 A6195611 A255223004 10050106 069C84C2-AW-AWS_PRIMARY 069C79A0-AW-AWS_PRIMARY A5728826 B203186402 A5105758 A5196350 A99155715 A5343519 A5117595 EW0112 SS0003 AW00107 EW0017 EW0030 SS0019 ST0010 EW0212 ST0030 SS0031 EW0306 EW0036 ST0046 EW0116 SK0030 EW0213 EW0004 EW0377 EW0376 SK5001 SR0002 ST0024 EW0114 SK0032 SS0029 EW0033 SS0039 ST0028 EW0370 SK0012 EW0370-AA-AW_Node EW0356 ST0059 SS0012 SL0022 EW0313 EW0384 EW0358 EW0357 SS0014 EW0013 EW0060 EW0035 AW00282 ST0050 SH0021 EW0353 SK0028 SL0013 SS0023 SS0022 SS0030 ST0054 SK0011 ST0045 SS0038 EW0206 EW0383 EW0364 ST0017 ST0015 EW0024 SL0020 EW0220 EW0105 SL0018 EW0031 EW0054 ST0051 ST0062 EW0007 SS0021 SL0033 ST0016 SS0027 EW0333 EW0393 SL0028 SS0026 EW0120 EW0104 SH0027 SS0004 SS0006 EW0324 EW0318 EW0214 EW0326 EW0305 ST0003 EW0053 EW0052 EW0387 EW0390 EW0390-AA-AW_Node SS0002 SH0010 AW00330 SK0031 ST0058 SR0003 ST0002 EW0113 EW0011 EW0382 EW0382_node EW0027 EW0045 SL0019 EW0335 ST0053 EW0389 SH0001 SR0004 ST0021 ST0034 EW0341 EW0340 EW0038 EW0039 AW00139 SS0024 EW0332 EW0363 JV0939 EW0325 EW0391 EW0321 SK0003 EW0339 EW0338 AW00027 ST0039 EW0019 ST0049 SS0025 SS0034 ST0052 EW0319 SS0035 EW0345 EW0002 EW0351 ST0040 ST0042 EW0020 SS0040 ST0057 EW0051 EW0041 EW0034 ST0007 SS0005 SS0020 ST0023 SS0008 ST0048 EW0320 EW0006 EW0316 EW0219 EW0050 EW0379 EW0378 EW0107 EW0347 PT0052 SH0014 EW0223 AW00225 EW0322 EW0329 EW0115 EW0349 ST0055 EW0349-1 EW0836 EW0209 AW00172 SK0014 SK0002 ST0029 ST0043 SS0028 SS0018 SL0027 SK0027 EW0025 EW0121 SL0030 SS0041 EW0359 ST0019 ST0060 ST0018 SL0021 AW00073 ST0012 ST0020 EW0001 SS0016 EW0003 SK0006 EW0344 EW0222 EW0037 EW0016 CT00346 CT00102 CT00160 NM00035 TAI106 BK0079 NM00042 CT00501 CT00177 CT00146 TAI062 BK0160 CT00308 TAI075 CT00147 TAI020 NM00024 CT00161 CT00251 TAI099 TAI066 PET00028 PET00045 CT00284 PET00030 000037 HD9230 CT00264 NM00063 CT00211 EW0312 CT00035 NM00014 CT00156 CT00163 CT00153 CT00210 CT00157 PET00041 PET00026 CT00134 CT00214 CT00125 CT00307 CT00165 CT00051 NM00023 CT00121 CT00434 PET00049 CT00268 TAI093 EW0131 CT00471 KW0007 AW00040 SL0012 AW00084 SS0013 EW0327 EW0392 SH0019 EW0350 AW00024 SL0014 SS0015 ST0044 SK0013 EW0123 SH0023 ST0041 EW0314 ST0006 SR0006 SL0025 SR0005 SL0017 EW0317 EW0331 EW0330 EW0023 EW0303 EW0032 EW0385 EW0388 EW0388-AA-AW_Node SK0034 SK0021 EW0301 EW0059 EW0103 EW0015 AW00130 SL0029 AW00045 SK0029 EW0352 EW0352-2 SL0031 ST0032 SS0046 SK0022 EW0315 ST0047 SK0017 SK0005 EW0101 ST0005 EW0368 EW0367 SR0001 EW0012 AWS00285 EW0348 ST0026 ST0061 EW0355 ST0035 EW0056 EW0102 SK0015 SK0035 EW0057 SK0009 ST0022 EW0221 AW00067 EW0217 EW0361 ST0038 EW0373 EW0372 EW0043 SK0020 AW00209 SK0010 EW0336 SL0016 EW0124 SK0001 SS0009 SS0036 SL0026 EW0310 EW0224 SK0025 EW0366 EW0365 SS0045 SS0033 SH0018 EW0062 SH0018H SS0044 EW0055 SH0016 EW0346 ST0013 SK0023 ST0056 EW0005 SL0010 EW0047 SK0016 EW0106 SH0024 SH0002 SH0025 SH0028 SS0011 SS0001 SS0017 EW0202 EW0010 EW0302 EW0328 EW0211 EW0337 SK0019 EW0026 EW0018 SS0032 EW0309 EW0354 EW0028 EW0203 EW0362 SS0037 EW0342 EW0334 ST0001 EW0046 EW0369 EW0042 EW0044 EW0029 SK0018 AW00167 EW0058 EW0048 SL0015 AW00321 SH0017 EW0343 EW0040 AW00044 EW0216 EW0311 EW0381 EW0380 EW0049 EW0014 ST0025 ST0011 ST0027 ST0014 AW00302 KA2737AWS1 KA3091AWS1 KA1174AWS1 KE6280AW01 To be provided 0850210938AS1 0850210994AS1 0850270650AS1 0850211007AS1 0850211012AS1 0850211063AS1 0850270756AS1 0850211069AS1 0850450226AS1 0850450223AS1 0850211135AS1 0850210984AS1 0850211023AS1 0850450215AS1 0850210923AS1 0850211035AS1 0850210887AS1 0850210933AS1 0850060773AS1 0850270612AS1 0850270606AS1 0850450202AS1 0850210962AS2 0850210962AS1 0850270720AS1 0850270775AS1 0850270521AS1 0850211064AS1 0850210959AS1 0850450222AS1 0850210953AS1 0850211001AS1 0850211017AS1 0850270658AS1 0850450208AS1 0850211129AS1 0850270584AS1 0850270509AS1 0850210875AS1 0850550300 0850210900AS1 0850210932AS1 0850210899AS1 0850210918AS1 0850210936AS1 0850210939AS1 0850450200AS1 0850210948AS1 0850450198AS1 0850270573AS1 0850270546AS1 0850450203AS1 0850270614AS1 0850260184AS1 0850210966AS1 0850210991AS1 0850210989AS1 0850270662AS1 0850211044AS1 0850211048AS1 0850211022AS1 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0850210764AS1 0850210732AS1 0850210757AS1 0850210755AS1 0850210807AS1 0004971617A 0850211128AWSEHL KRAS54877111 0850210735AS1 0850210746AS1 0005435859A 0005452095A KRAS55440261 KRAS55567071 0850210806AS1 0850210835AS1 0850210751AS1 0850210720AS1 0850270481AS1 KRAS54893311 KRAS55395581 KRAS55199661 KRAS55749261 0005470350A KRAS55252361 KRAS54972221 KRAS55567021 KRAS55567011 0850450175AS1 0850210938AWSEHL 0850210727AS1 0850210750AS1 0850210773AS1 0850210690AS1 0850210728AS1 0850210725AS1 0005443399A 0005420279A 0850211121AWSEHL 0850211054EHLAWS KRAS55424681 KRAS55188901 0850270436AS1 0850210733AS1 0850210793AS1 0850210710AS1 0850210740AS1 0850210830AS1 0850210752AS1 0850270504AS1 AW52642138 KW1013AW15 KW1100AW04 KW1067AW01 KW1011AW06 KW1005AW20 KW1005AW16 25207406 KW9580AW 96501PAC91 96501PAC90 KW101 KFASAW 965K20 KW1007SV30 AWS9216 KHAWS9600 KW9755 KW9278 256E6168-AW-AWS_PRIMARY KW1004AW36 KW1155AW06 LV4041AW03 AW55509562 LV4000AW09 AW51814481 AW51900641 LV4001AW07 LV4001AW10 AW52182292 AW54274691 AW54892842 LB1331AW09 961PAC10 BMCAW 4496308 OM1007AW03 LT4001AW16 LT4129AW01 LT4001AW17 AW52186341 AW53459591 LT4110AW01 ltdatvln-aw01 LT4006AW03 LT4124AW02 AW54465401 LT4003AW02 AW54465301 LT4028AW02 aw55718721 LT4089AW02 LT4069AW02 LT4069AW01 LT4122AW01 LT4000AW15 LT4026AW07 LT4079AW02 AW52568872 PLIMCRZE1AWS AW54934902 110807OT13 200012OT01 1553AW0035CT2 0004190980D 06AF654F-AW-AWS 1553AW0020CT2 1553AW0022MR1 sdgpacvpaw03 sdgpacvpaw02 06969957-AW-AWS_PRIMARY 1553AW0025CT1 0005449852A 0834550071AWSER 1553AW0011CT1 1553AW0029CT2 PPUMAW35 PPUMAW34 PPUMAW33 1553AW0044CT1 HPUAWS 1553IT0014 IIUMMC-AWS 486CD21A-AW-AWS_PRIMARY 1553AW0030CT1 1553AW0023MR1 0834490066AW2 069CE52E-AW-AWS_PRIMARY 0834490066AW1 0691E817-AW-AWS_PRIMARY 0005456789A 1553AW0034CT1 IOCKL-AWS 1553AW0024CT1 06BAA061-AW-AWS_PRIMARY 0005456791A 0691699D-AW-AWS_PRIMARY 0005456793A 1553AW0033CT2 MT1014AW04 MALTA10 2M223804MW HCIT4753028AW HCIT4376494AWS CJRBX1800011AW HCIT4665855AWS01 HCIT4665855AWSSUR HCIT4665855AWSMEX HCIT4820102AWS HCIT4665855AW HCIT5497413AWSSUR HCIT4429184AWS HCIT4825663AWS HCIT4579183AW 0004568789 HCIT4468687AWS HCIT4711469AWS CTDGV1800001AW HCIT4730432AWS HCIT4784198AWS AW52863172 MD1055AW02 MD1076AW01 MD1145AW01 AW52900192 AW52863192 AW52554872 AW52863072 AW52863123 AW52862781 MA1841AW01 AW49901282 MA1942AW01 AW48582681 AW52293331 MA1047AW03 MA1780MR01 MA1134AW03 MA1509AW01 MA1955AW01 MA1884AW02 AW50547782 MR1002AW02 MA1908AW01 MA1938AW01 MA1421AW04 AW51685322 AW51674972 AW52298392 AW50497272 MA1493AW04 AW52509941 MA1779AW01 AWS47942321 D90FD1F3-AW-AWS_PRIMARY AW53288172 AWS49900971 MR5340231AW1 AW53401992 AWS53057821 MA1148 AW52300402 AW52299022 AW52299021 AW52298832 AW52293211 AW5226643 AW1516 AW54169842H AW54169842E AW54169842B AW54169842A AW54169842 AW53198711 AW54169842G MA5361645AWS AW53932381 AW52299621 MA1339AWS01 MA1895AW01 MA1548AW05 AW51168922 AW52294081 AW49900202 MA1881AW03 MA1054AW03 MA1864AW01 MA1420CT02 AW54169842F MA1843AW03 MA1528AW03 MA1528AW02 MA1690AW04 MA1855AW01 MA1135AW02 AW54582352 MA1711AW04 MA1818MR01 MA1818AW01 MA1956AW01 AW50554842 MA1877AW06 MA5520791AWS NPAWX26627367 083049007184822 AMS03200 AMS1323 DBS0823 DVT01201 ENS0121 GRN1121 HLM06201 LWD0322 LDD0420 MST0121 RTD0192 RTD01206 RTD0722 SPK0125 TLB02202 ZWL0620 NZAWX25209812 85103833082 85178504240 85202521492 85103832554 85176909731 83180471123 85136254180 859AW000226CT1 85204792617 85170051006 85205055892 859AWS000189CT1 859AW000189CT2 85116842625 85109909109 85166750480 85AW0000011CT2 85AW0000011CT3 NO1054AW01 NO1194AW01 NO1146AW06 NO1011AW20 NO1146AW07 NO1070AW01 NO1136AW02 NO1018AW02 NO1028AW01 NO1102AW01 NO1087AW01 NO1012AW05 NO1051AW03 NO1043AW06 NO1047AW01 NO1260AW05 NO1043AW07 NO1016AW13 D26C48A0_AW_EDISON_AWCT NO1259AW03 NO1035AW05 NO1035AW06 NO1088AW04 NO1068AW12 NO1068AW11 OM1025AW01 AW52216701 DIWANSYSID1 AW53433002 D9311320-AW-AWS AWS54203001 OM1013AW02 OM1010AW03 PK1689AW01 AW51128742 AW51129812 PK1365AW01 PK1365AW02 PK1722AW01 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PL1524AW03 PL3116AW05 PL1601AW01 PL1502AW04 PL1502AW03 13137819 PLIMCRAD1AWS01 PL0030AW01 PL1190AW09 600034AW04 PL1491AW13 PL1337AW03 PL1190AW10 PL2027AW01 PL1445AW01 PL2342AW05 PL1651AW02 PL1651AW03 PL1651AW05 PL1107AW12 P00786AW01 PL3859AW01 PL1150AW11 25FDDCC0-AW-AWS_NODE PLDATWAR-AW2 600151AW06 PL3331AW05 PL0635AW01 PL1007AW03 PL1234AW04 PL1050AW03 P00326AW01 PL0080AW03 PL1840AW01 PL1640AW04 PL1640AW06 PL1599AW02 PL1684AW02 PL0217AW01 PL1692AW01 08081899 PL3182AW02 PL1655AW02 PL1774AW03 PL1606AW05 P00329AW02 PL0195AW06 P00467AW01 600092AW10 PL1176AW01 PL0399AW01 PL3811AW01 PL1169AW04 600092AW11 PL0714AW02 PL1010AW03 600042AW20 PL1147AW03 PL1600AW06 PL1600AW05 PL3529AW06 PL1316AW01 600062AW05 600062AW06 P00212AW01 PL2057AW01 PL1065AW08 PL1523AW04 PL1674AW08 PL1040AW03 P00549AW02 P00549AW01 PL1780AW07 P00792AW01 PL2773AW05 PL1709AW04 PL3811AW04 600042AW25 06987654-AW-AWS_PRIMARY PLDATWAR-AW1 PLIMCWAR3AWS PLIMCPOZ1AWS01 PLIMCSZC1AWS01 13864822 PL1725AWS1 PL1377AW01 PLIMCWRO1AWS01 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PRECISIONMEDAWS1 VNAW5320632A (Updated 3/11/2026) Additional System IDs 708425CTRVEHLAWS 718226APEXAWS WPHTMP 216844SMARTSUBAWS1 210575AW2 AUAWX26631168 AW52743961 HCIT5574699AWS HCIT5476277AWS HCIT5317135AWS CBDMG2300090AWS 604682AWS2 5454275AW41 5454275AW61 CBDWG2400077HMAWS 82427030241 15585407AWS 9429976 15169963 15391391 07577111 14829089 14830987 14696567 15533573 15706077 14829090 15561104 15658050 15525972 14759893 83049002220925 INAWX26381846 INAWX26563044 INAWX26381882 INAWX26381851 INAWX26596378 11960519 12094344 tpacsaw01 EW0392 SH0022 15432088 0850450224AS1 3BD9E8F8-AW-AWS_PRIMARY LV4001AW10 BMCAWSN AW54169842I AW55624592 AW55686451 MA1864AWS01 NZAWX25209812 14497283 14795021 RU4929AWS1 RUAWX26411049 RU5494AWS1 6073AW0020CT1 SGAWX25083035 L001AWS02 12597870 THAWX24852951 THAWX24988201 13745670 13748593 15875772 ANKAWS HUAWS AWS55342661 13352728 13360177 HCIT5303285AWS HCIT5393306AWS
FEI Number 1000284313
Recalling Firm/
Manufacturer		 GE Medical Systems, SCS
283 rue de la Miniere
Buc France
For Additional Information ContactGE Healthcare Service
800-4371171
Manufacturer Reason
for Recall		Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
FDA Determined
Cause 2		Software in the Use Environment
ActionOn September 5, 2025, firm began deployment of customer letter. Customers were informed they could continue use of their device by following the instructions provided: 1. Ensure the AW Server is installed on a facility internal network, that is not accessible from any public network. If access to AW Server from outside the facility network is desired, this connectivity must be configured to be usable exclusively through the facility s Virtual Private Network (VPN) or equivalent network security solution as described in your AW Server s Pre-Installation Manual that is available in the Customer documentation portal. NOTE: Access management to the facility s internal network on which the AW Server is installed on, and management of the network security solution is under the strict responsibility of the facility. 2. Ensure strong, secure passwords are configured for the AW Server. 3. GE HealthCare recommends that organizations follow security and cybersecurity best practices, including securing the network where AW Server is connected.
Quantity in Commerce7,302 (1,381 US; 5,921 OUS)
DistributionDomestic US distribution nationwide. International distribution worldwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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