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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Enterprise Archive

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 Class 2 Device Recall Centricity Enterprise Archivesee related information
Date Initiated by FirmJuly 31, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3166-2026
Recall Event ID 99661
510(K)NumberK043415 K110875 
Product Classification System, image processing, radiological - Product Code LLZ
ProductCentricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
Code Information UDI-DI: V4 - 00840682102766; System IDs: CARTI02312615 CARTI22225617 520784EASFTW1 19233337_EA MARICOPAC02308032 602406SAEAFSW 602997SAEASW-24 SVRHC14765622 520458CVEASW 520780SAEASW 520784EASSASW 520629EA1 BERMUDACA02257222 BERMUDACA02257223GW ASHPACSEA1P 805395EASW PMHD15081203 805725EASW1 V5SPORTS01804915 559582CAEASW 760775CAEASW 310673CAPACSSW UHVNAEAPRD01 UHEAVNATEST01 UHVNAEAPRD02 UHVNAEAPRD03 UHVNAEAPRD04 UHVNAEAPRD05 UHVNAEAPRD06 310349EASW1 310349EASW2 310349EASW3 310ODCEASW4 ADVENTIST02256061 323726CAEASW NDMGCAWEB PALMDALEM02354935 PALMDALEM19604722 PALMDALEM19604723 661948ISBSW 818676EA01 916781MMBSW1 916781MMBSW2 ADVENTIST1474489 SUTH20087395 707554EASW 916733EASTSW1 916733EASTSW2 916733EASTSW3 916733EASTSW4 916733EASTSW5 916733EASW2 916733EASW3 916733EASW4 916733EASW5 916733SAEASW SUTH20992909 SUTH20992910 SUTH20992912 SUTH20992914 650696EASW 408590EAAIMSW 805542SAEASW VSMY01820424 VCM01983687 SONORAREG26747425 RANCHO02255035 RANCHOTEA01 RANCHODTEA01 UHS24494273 VCM01819620 CWHMC01821420 303584CVEAFSW 303584EASW3 303584EASW1 303715CVEASW GRHD16174555 203384CAEASW 202745CAEASW 302674CCASW 01730933BAYHEALTH JFKR21743924 LAKESIDEM02275735 727462EASW 772468EASW-SAAIM2 EFDVWPTCMAIM04 352333AIMEASW 352331EACCASW 352331EASW BIHT22108325 BHIT11111111111111 ORMC320536538 LARGOMEDI24412138 305223EASW-SAAIM2 DAVIEMEDI20960878 305223EASW-SAAIM3 239860SAEASW 352237CVEASW UCFNONAL20037311AWEA PCMC4-20940705 850494EASW 904819EASW1 904819EASW2 941342EASW HRMT19664009-AIM01 888663AFEASFTW3 VSMAF02345970 BYH02360323EA1 MCC15961440EA NORTHE14610617 BYH14776394AIM1 BHY14776395AIM2 BHY14776396AIM3 BHY14776397AIM4 BYH14929313EA2 BYH14929315EA3 813971ECVPACS 954688EASUV100 NGDC01893571 813873CASAEASW HLEEMOFF21014281 HCAWESTF24284158 BYH26758983CCAEA6 BYH26758991CCAEA7 TRMCN19965352 901392EASW TRMC-21771222 407777EASWT 407777EASW1 407777EASW4 21300644EASW 21301799EASW 21301800EASW 21301807EASW5 706651CVEASW 706596CAEASW 912276EASW 706272CCABSW HMC720996757T 404501EASW1 404501EASW2 706754EA1SW 404605SFEASW 404605EASW 406238EASW VSMZ01812194 319388EADBT 641422EASW CWVM24336377 IFCH02344193EAAPPTEST IFCH02368939EAAPP IFCH02369613EA2APP 847618EASW1 847618EASW2 26832372EATest ANNROBE19660175 ANNROBE19660178 RPS19736388 RPS19736389 773880EASW1 773880EASW2 795079OEASW 795079REASW 312996SAEAAIM01 RCTI01804917 312996SAEAAIM02 815285EASUV100 ALEXIAN02173643T 847657EADBT 708202CVEASW 847ABEASW 847SAEASW LaitekDataMigrationCPACSLabEA 309962SSASW_EA 618436EASW S046EASW2 S801EASW1 GSRHC22096532 S801EASW1A AAHCPACSARCHP2APPN1 AAHCPACSARCHP2APPN2 PIPELINEH19666526CCAT PIPELINE19666739S2 PIPELINEH19666740CCAN1 PIPELINEH19666741CCA 815824EASUV100 MPAL1454994 ADVPACSAIM151 ADVPACSARCHT1 ADVPACSARCHT2-NEW AAHCPACSARCHP1APPN1 AAHCPACSARCHP1APPN2 ADVPACSAIM87 630963AIM151 ADVPACSAIM58 ADVPACSAIM86 ADVPACSAIM101 ADVPACSAIM102 ADVPACSAIM61 ADVPACSAIM59 ADVVNAAIM192 ADVVNAAIM193 ADVPACSAIM145 ADVVNAAIM194 ADVVNAAIM003 815398EASW 847657SAEASW 765561SAEASW LRHS19716184 765983EASW THRH20280221 316706EASFTW 502226EASW-EAPROD FRMC22295734 606439CAPACSSW 606679CAEASW RRMC120606244 985230EASW-EA82 PACSEAT1 985785EASW CFO18227237 985LVWEASW 504380CAEASW HTMC23300064-AIM OVERTON20031487 318221CAEASW 337527CAEASW TRM20095296 TRM20095297 PHS20915074 PHS20915379 PHS20915380 PHS20915381 PHS20915382 PHS20915383 PHS20915384 PHS20915385 PHS20915386 PHS20915387 PHS20915388 PHS20915389 PHS20915390 PHS20915391 PHS20915392 978937CAPACSSW TLGH24854574 PHS16023953 PHS20915339 PHS20915340 PHS20915341 PHS20915342 PHS20915343 PHS20915344 PHS20915345 PHS16023953 PHS20915347 PHS20915348 PHS20915349 PHS20915350 PHS20915351 PHS20915352 PHS20915353 PHS20915354 PHS20915355 PHS20915356 PHS20915357 PHS20915358 PHS20915359 PHS20915360 PHS20915365 PHS20915361 PHS20915362 PHS20915363 PHS20915364 PHS20915366 PHS20915367 PHS20915368 PHS20915369 PHS20915370 PHS20915371 MDCVPAPP31 MDCVPAPP32 MDCVPAPP33 MDCVPAPP34 MDCVPAPP35 MDCVPAPP36 MDCVPAPP37 MDCVPAPP38 MDCVPAPP39 MDCVPAPP40 MDCVPAPP41 MDCVPAPP42 MDCVPAPP43 MDCVPAPP44 MDCVPAPP45 MDCVPAPP46 MDCVPAPP47 MDCVPAPP48 MDCVPAPP49 MDCVPAPP50 781979EASW1 781979EASW2 MELROSEWA20583692 978686EASW EACCA02041028 EACCA20915282 EACCA20915283 EACCA20915284 EACCA20915285 EACCA20915286 EACCA20915288 EACCA01601430 EACCA20915316 EACCA20915317 EACCA20915318 EACCA20915319 EACCA20915320 EACCA20915321 EACCA20915322 EACCA20915323 EACCA20915324 EACCA20915325 EACCA20915326 EACCA20915327 EACCA20915328 EACCA20915329 EACCA20915330 EACCA20915331 EACCA20915332 EACCA20915333 EACCA20915334 EACCA20915335 EACCA20915336 EACCA20915337 NDHMVPAPP20 NDHMVPAPP31 NDHMVPAPP32 NDHMVPAPP33 NDHMVPAPP34 NDHMVPAPP35 NDHMVPAPP36 NDHMVPAPP37 NDHMVPAPP38 NDHMVPAPP39 NDHMVPAPP40 NDHMVPAPP41 NDHMVPAPP42 NDHMVPAPP43 NDHMVPAPP44 NDHMVPAPP45 NDHMVPAPP46 NDHMVPAPP47 NDHMVPAPP48 RSCHVPAPP09 NDHMVPAPP49 NDHMVPAPP50 RSCHVPAPP01 RSCHVPAPP02 RSCHVPAPP03 RSCHVPAPP04 RSCHVPAPP05 RSCHVPAPP06 RSCHVPAPP07 RSCHVPAPP08 RSCHVPAPP10 RSCHVPAPP11 RSCHVPAPP12 RSCHVPAPP13 RSCHVPAPP14 RSCHVPAPP15 781344EASSA BERH02265911T 413447EASW2 413447EASW3 781624SAEASW1 410328SAEASW FMH21296028 FMH21296040 NORTHE02315656 269245SAEASW 313745CAPACSSW3 517353EASW 906387EASW 248858EASW 586573SSAEA 850912EADBTSW 651859EASW1 651859EASW2 651859EASW3 417820SAEASW 417312SAEASW 417269CAEASW 662624EASW VSMP01454845 228497CAEASW ROH19600630 601200RDMSEA2 601200EASW1 601200EASW2 601376EASW1 601376EASW2 601936EASW SCRMC20483088EASW 601426CAEASW 228497CAEATSW 601833EASW 406237EASW2 BC14767334EASW3 BC14767335EATSW 828326EASW1T02339893 CTV20092639 828326EACCASSW 828326EASW1 828326EASW2 CTV01440395 BJRH01458274 402484EASSW 402484EASW 22195055EASWT CTH19661473 603669SAEASW CTH22220612 CTH24306635T BLH01451962 BLH23256939 BLH23257090 BLH23257099 BLH23257110 SHS301815017 SHS320686077 ACMC102040128 609652CCASW 201568SAEASW VTH24285546 VTH24285547 VTH24285548 VTH24285549 VTH24285550 VTH24285552 VTH24336370 VTH24336371 856342EACCAUBS 856342EACCASSW RFP20892096 RFP20892098 RFP20892099 RFP20925842 RFP20925844 973754CAEASW 973754CAEASDWSW 505848CAEASW SJRM20878160 sanjpacslta01 sanjeadr01-21311164 505368EAFSW VSMAI01453994 702731CPEASW 702731AIMEA1 NORTHERN-N20642317 NORTHERN-N20642318 NORTHERN-N21785088 NORTHERN-N21785090 NORTHERN-N24465565 NORTHERN-N24816038 STO01813996 STO22273303-AIM2 STO21290515 516796SAEASW BLH01442247 BLH01451962New 718246CAEASW LISSP02254841 LISSP26655432 STO01813998 STO20096747T2 STO20980786ELIH STO21208312PRI 845343CAEASW 315798EASW 315798EASQLSW ERM16295282 MSI16867949 MSI16932938 MSI16932939 MSI16932941 MSI18867284 MSI00108861 MSI00108862 MIS00116904 MSI00116905 MSI01370531 MSI01974717 NEWYORK01976549 MSKC01981432A EA01291516 516473CVEASW MSI00161353 516763EASW1 516763EASW2 518382CAEASW STO02291566 STO20284578T2 631444EADBTSWT2 631444-EA26918110 SUPS16265098 914681EASW-old WPHC121007660 914681EASW 718920AFEASFW1 718920AFEASFW3 NSLI16234723 718920AFEASFW 330543EASW1 330543EASW2 513541SAEASW 614722EASW1 614722EASW2 614722EATSW MARKHZAN01465407 937548SAEASW 937548EADBT 740886EASUV100 937239CARASW 937440EASW STMARYS-TEA STMARYS-PEA 918231EASW1 918599CAEASW SKLC16054454 503257EASW Not Available SLHT14765263 SLHT14898836 SLHT20679053 SLHT20070917 484SCEASW 484TPEASW SLHCAEASW SLHT20677333 SLHT20677335 SLHT20679056 SLHT20679058 TRSTATEP01444623 717253EACCASW WYMH23199026 QUANTUMIM14640636AIM1 QUANTUMIM14776681AIM2 QUANTUMIM14776682AIM3 QUANTUMIM14776683AIM4 QUANTUMIM14776686SF1 QUANTUMIM14776694CCAT1 QUANTUMIM14776698CCASN2 QUANTUMIM14776699CCAN1 QUANTUMIM14776701SF2 QUANTUMIM14776698CCASN3 QUANTUMIM21737523TAIM1 724728EASW1 724728EASW2 HVH02179412 HVH02179414 HVH23169315 TJFH19600521 215955CAEASW TJFH21307141 610341EAAFSW 215335NAZEA 412802CCASW2 412623CVEASFTW 412802CCATSW UHS101383445 UHS101404910 UHS101816976 UHS120872706PF UHS120872709DRP UHS120872712DRS UHS120872720PEAAN1 UHS120872722PEAAN2 UHS120872729PEAAN3 UHS120872732PEAAN4 UHS120872733PEAAN5 UHS120872735PEAAN6 UHS120872736PEAAN7 UHS120872739PEAAIN1 UHS120872740PEAAIN2 UHS120872758PEAAIN3 UHS120872759PEAAIN4 UHS120872760PEAAIN5 UHS120872762TEAAN1 UHS120872769TEAAN2 UHS120872770DREAAN1 UHS120872771DREAAN2 UHS120872772DREAAN3 UHS120872773DREAAN4 UHS120872775DREAAN5 UHS120872776DREAAN6 UHS120872777DREAAN7 215453EASW1 215453EASW3 610988CAEASW1 610988CAEASW2 LFHNK16295275 401444EASW2 LFHNK20582700 LFHNK20582701 LFHNK20582703 LFHNK20582705 LFHNK20582707 LFHNK20582746 LFHNK20582747 LFHNK20582819 864716EASW1 864716EASW2 864716EASWT 803461EASW 843789SAEASW VSMAT01805254 843347EASW1 843347EASW2 843674CAPACSSW RALPHHJO24813471 843431EASW AIMC19739264 803329CAEASW 803791EASW 605217EASW2 FLANDREAU01891218 605882EASW WHS620094946EASW 423493SAEASW 423431EASW2 865544SAEASW 928758CAEASW 931393EASW 409924SAEASW DCHVPACSAIM DRISCOLLC20274988 DRISCOLLC20946818 HPN102354108 HPN102354110 HPN102354112 HPN102354114 HPN102354116 HPN14580252 HPN14580253 HPN14580246 HPN14580248 HPN14580249 HPN14580250 HPN14580251 214324CARASW HPN101987755 DOCTORSHO20903659EAP HPN120698801 HPN120698826 HPN120698836 HPN120698838 HPN120698839 HPN22107311 TTU01446990 DSMC22156462AIM HCANORT20536098 817255SAEASW HCANORT20650740 956357SAEASW MTT17192645EAAPP244 MTT17192652SAAIM161 MTT17192654SAAIM162 MTT17192655SAAIM163 MTT17192656SAAIM164 MTT17192661EAAPPTEST 281420EASW 713441EASW 713533SEARSW 713704SAEASW 713704SAEASW1 ISD713EASW1 ISD713EASW3 MTT01810261 MHHS01977631 VSMHA01893554 DHOL20072291 DHOL20072292T DHOL01810759 DHOL20788665 DHOL20788666 VSMU02035194 LUBBOCKHE19706783 22219325PEAAPP HPN02255714T HPN102354124 HPN102354128 HPN102354130 HPN102354131 HPN102354132 HPN102354133 HPN102354134 HPN102373851T HPN14580257 HPN14580261 HPN14580262 HPN14580263 HPN14580264 254724EASW1 HPN101435912 HPN101987766 HPN120621981 HPN120621982 HPN120621983 VASOY02315722 361572EASW 801377EASW SMH820582755 SMH820582756 352615EASW 540776EASW 425688SAEASW 425374EASW 206321CCABSW 206292EASW4 206292EASW2 UWH22158915 UWH22158917 UWH22158918 UWH22158919 WFW414EASW4 WFSI02183319 WFSI02255805 WFW20496802 WFW414EASW1 WFW414EASW2 WFW414EASW3 WFW414EATSW 920261EASW 304623EASASW 304487EASW3 304487EASW1-R 304797CVEASW DZ1906PP01 DZ27??PP01 DZ1128PP01 DZ2763PP02 DZ2373PP01 HCIT4825134PACS HCIT5213068EA HCIT5213068EA 000009335-Centricity Enterprise Archive-24509241 HCIT4859945EA 83191934072 0910558008 0910558008 834IT000002 0910553037 0910553037 83177663003 AH4325PC02 AP9147PC01 AH5291PC03 AH0104PC01 AP6264PC02 01452306 AH0106PC01 HSSTEA01 HSSTEA02 030157ST02 030157ST04 040164ST01 040164ST04 040164ST04 300013ST01 HCIT4691866EALTS HCIT4691855EA HCIT4759526EALTS za00122 HCIT7102800EA HCIT4852374EA HCIT4860936EA HCIT4290686EA HCIT1725478EALTS1 HCIT4990321EAGW HCIT7103264EA HCIT7104315EA HCIT5245248EALTS HCIT5245248EAGTWPO HCIT5245248EAGTWIP HCIT5245248EATEST HCIT5245248EAGT-ST HCIT1424246EA HCIT1424246EA 604875EAKDC 604875TESTEA 604520AIM40 604520EA40ISITE 604520TESTEA 250565AWEACACHE 604586EA 604586EA40MAMMO 604586FHAWEACACHE 604586AIM40 604586ECHOEA 604875EAMAIN 709752NLEA1 709752EAGATEWAY 709752NLEA2 709752TESTEA 519426AIM 519426TESTAIM 905521CWEA1 905521HHSTESTAIM 905521HHSAIM 905522SJHHAIM 905522SJHHTESTAIM 905521TESTCWEA1 613548EAHDIRS 613548TESTAIMRET 613548TESTEA 613548AIMRET 613548EALEGACY 905575EA 905895DIEA 905895TESTEA 613732AIM 613732XEDEA 613732TESTAIM 705523EAAPPB11 705523EADBB 705523EA-B 705523EAAPPB1 705523EAAPPB2 705523EAAPPB3 705523EAAPPB4 705523EAAPPB5 705523EAAPPB6 705523EAAPPB7 705523EAAPPB8 705523EAAPPB9 705523EAAPPB10 416326EA 416813DREA40 416813AIMARC 416813AIMRET 416813EA40 416813DRAIMARC 416813DRAIMRET 416813TESTAIMARC 416813TESTAIMRET 416461EA 905372TESTAIM 905372EA 905372AIM 705675EAAPPA10 705675EAAPPA11 705675QAEAAPP1 705675EADBA1 705675EADBA2 705675EAAPPA9 705675QAEAAPP2 705675EAAPPA1 705675EAAPPA2 705675EAAPPA3 705675EAAPPA4 705675EAAPPA5 705675EAAPPA6 705675EAAPPA7 705675EAAPPA8 705675QAEADB 705675TESTEA 705675QAEA HCIT4567313EA HCIT5026141EA Not Available 082455160221 082455160237 082499180102 082499190198 082445110005 082455060001 tbd 082499130790 082499130124 082499020074 082499030205 SiteID-Centricity Enterprise Archive-20608302 SiteID-Centricity Enterprise Archive-20608323 SiteID-Centricity Enterprise Archive-20608324 SiteID-Centricity Enterprise Archive-20608390 SiteID-Centricity Enterprise Archive-20608393 SiteID-Centricity Enterprise Archive-20608394 SiteID-Centricity Enterprise Archive-20608408 SiteID-Centricity Enterprise Archive-20608410 082455040342 SiteID-Centricity Enterprise Archive-20637766 082455040321 082499290047 082499290047 082455040025 1359772-Centricity Enterprise Archive-21327383 082421230658 082499220115 82455230016 082455030073 82455150068 82455150074 SiteID-Centricity Enterprise Archive-20608838 082455180040 082499180080 082499060054 082499100395 SiteID-Centricity Enterprise Archive-20594649 SiteID-Centricity Enterprise Archive-20594650 SiteID-Centricity Enterprise Archive-20606492 SiteID-Centricity Enterprise Archive-20595019 SiteID-Centricity Enterprise Archive-20541554 647002-Centricity Enterprise Archive-22252504 82499100387 082499100394 SiteID-Centricity Enterprise Archive-20606493 082433120225 082455180042 082455180041 SiteID-Centricity Enterprise Archive-20594360 082455120545 082499100188 82455290014 082421130135 SiteID-Centricity Enterprise Archive-20611137 SiteID-Centricity Enterprise Archive-20611755 SH-CH-Centricity Enterprise Archive-20614728 82455130335 82455130055 82455130394 82455130224 082499180085 082455160035 82455120514 SiteID-Centricity Enterprise Archive-20594353 82455120227 JS KUNSHAN 123253814 82455080025 SiteID-Centricity Enterprise Archive-20608412 082421050162 SiteID-Centricity Enterprise Archive-20608172 417238-Centricity Enterprise Archive-21273761 082455050069 tbd 082427150109 082455130415 082499310137 082499130813 082499130813 082499130813 082499130813 082499130813 082499130813 082499130811 13767625-Centricity Enterprise Archive-21273766 082455080027 82455120448 82455120448 082499100401 SiteID-Centricity Enterprise Archive-20594911 SiteID-Centricity Enterprise Archive-20606528 SiteID-Centricity Enterprise Archive-20611846 082499310166 SH EASTERN HEP24523160 082499310161 082499230207 082499230207 082455140069 082455140085 HCIT1630952EA-APP HCIT4946501EA HCIT4277575EA1 HCIT4692615EA HCIT4796839EA EG1017PP01 Not Available GE2000 Hansa1234 ZA2879PP03 To be defined M4477016 A4167672 E4167639 A4498647 NA 89980420081077 M61421914 M100323906 M100323908 A4171560 M4171829 M2753416 M4476431 X59655541 Not Available M4206536 M5172580 M5172550 P4172842 M23084326 B1965419 B1965420 MQ1234509 MQ1234504 20031339 M4485024 M4485024 M4482630 NC1075PC01 M386578308 M117165201 20031333 A2741114 A2741111 A5485260 A5485261 M4144129 DC GHT13 - Test - EA4 DC GHT13 - Prod - EA4 Server 1 DC GHT13 - Prod - EA4 Server 2 DC GHT13 - Prod - EA_C360 M4188439 I9237517 M5480763 AHP24908218P NC1028WS01 NC1028PC01 M4712027 A9190158 A9190159 M4491543 PF1000PC05 M7417701 M4143983 M220995204 02398906 M117565101 M4825003 M4204530 M4484531 M838835606 D4858908 M4209922 M348856923 M348856925 M4487540 M348856912 M348856913 M348856919_EDLC_EA_DataCenter M143153111 Utuora M4217627 M4505283 M4505294 A2943407 M454662403 HC0399PC02 tobecreated PC1695PC02 511349PC01 609334PC01 HC4348PC02 HC1451SV03 HC2636PC02 744459PC02 511685PC01 HBON01PC01 387042PC02 518086PC01 PC3003PC01 HC1249PC01 02093419 HC0074PC02 PC0114PC02 HC3643PC01 HC1666PC02 387194PC01 HC9502PC01 UESS01PC02 126292PC02 UJJF01PC07 n/a 530366PC01 416005PC01 HC4014PC01 NA HC0468PC01 600791PC01 556162PC01 HC0727PC01 362520PC02 HHAN01PC02 UHAN01PC03 HHEI01PC02 374565PC01 evkhcr-26921624 410014PC01 HC1992PC03 HC5284PC05 HC2554PC03 490661PC01 HL0090PC02 624751SV03 CC0668PC02 NA HC0014PC02 HX1642PC01 145774PC01 HCNE01PC01 HC1819PC07 HC0094PC01 553160PC01 434487PC01 n/a HC0536IS02 Not Available UC4372PC03 UC4372DMEA01 509585PC01 HC0565PC02 HC0863PC02 HC1282PC01 424881PC02 TBD NA TBD H1892IIS14 H1787IIS21 TBC TBD H44432AW24 TBD 828550053 0828550074 0828550114 828550079 0828550070 0828550072 0828550083 0828550068 0828550068 0828550074 828550064 828550052IB01 828550064 828550020 828450021AWSEA 828550056EA1 828550058 0828550020 0828550089 0828550091 828551005EA1 SiteID-Centricity Enterprise Archive 4.0-20608845 828550095 N.A. 0828550082 0828550071 0828550071 0828550067 0828550109 828550057 HU1697SW01 TBD Not Available TBD_SAN_EA AIIMS-MANGALAGIRI-EA SIDDHARTHA_EA CARE-VIZAG2-EA-ROUTER PGI-EA-001 083055283270418 EA-HLL-AIIMS-RAIPUR-1 CARE-RAIPUR-EA 083055003435816 083055003435816 MAX-DC-EA MAX-DC-EA-LTA AIIMS-EA-0001 083055247345716 EA-AIIMS-NCI-JHAJJAR-01 Not Available 083055820666518 MCC-EA SCTIMST-IN-EA RCC_EA SIRHNHOSPITALTRUST-EA 083055201766451 Wockhardt-EA 083055211206517 CARE-NAGPUR-EA-ROUTER AIIMS-NAGPUR-EA 083055209510118 ACTREC26874956 CARE-UC-EA-ROUTER CARE-MC-EA-ROUTER CARE-RC-EA CARE-CN-EA-ROUTER CARE-CH-EA-ROUTER CARE-GCN-EA-ROUTER CARE-VZH-EA-ROUTER CARE-CM-EA-ROUTER CARE-QCOP-EA-ROUTER CARE-CHB-EA AIIMS-NM-EA KMCH-SULUR-EA CARE-VIZAG-EA-ROUTER SIKSHA-EA CARE-BBSR-EA JIPMER-EA-LTA JIPMER-EA-SHADOW JIPMER-EA-ROUT PBM-EA-001 083055803467916 KMCH-MAIN-EALTA SRK-EALTA KMCH-KP-EA KMCH-MAIN-EA-ROUT NARUVI-EA CMC-Centricity EA-01 CARE-DC-EALTA 083055840003710_EA NIZAM-EA MNJ-EA CARE-OP-EA-ROUTER CARE-MC-EA-ROUTER CARE-MUSHEERABAD-EA-ROUTER 263394-Centricity Enterprise Archive-27109645 CARE-NAMPALY-EA-ROUTER CHL-EA CARE-HITEC-EA-ROUTER 083055604732915_EA SouthEastRAILWAY-EA HSCC_CNCI_KOLKATA_EA RSMITRAKELUARGABINTARO-EA RSUDBERKAHP-EA RSMKG-SERPONG03 BETHSAIDA-EA RSUDMukomuko-EA INDRIATI001 RSMKKEMAYORAN-EA RSUDKOTAJOGJA-EA RSHARAPANKITA-EA RSUDTarakan-EA PTMKMas05 PTSentosa3 RSUPFATMAWATI-EA RSPOLRIB-EA SULIANTI002 RSMK-KelapaGading04 PTUROGEN05 SiteID-Centricity Enterprise Archive-20535379 RSUDHMB-EA HASANSADIKIN-EA RSMK-Cibubur04 MKCikarang-EA MKBekasiBarat-EA MKBEKASITIMUR_EA RSUDBEKASI-EA RSUDCIAWI-EA RSMITRAKD-EA SYAMSUDIN005 RSUDPandanArang-EA RSUDDRMAP-EA RSUDKRMTW-EA RSJDSurakarta-EA RSDDRSJ-EA RSUDPasirian-EA RSUDSidoarjo-EA RSMITRAKW-EA RSALDr.Ramelan-EA RSHajiSurabaya-EA RSPHCSurabaya-EA RSUDTuban-EA RSUDKabupatenB-EA RSUDTarakanKaltara-EA UripSumoharjo1 RSUDLeimena-EA RSBINTARO05 MITRAKELUARGATEGAL-EA RSUDDRHKB-EA RSUDBHAKTIDHARMAHUSADA-EA RSUPSOERADJI-EA MitraKeluargaDeltamas-EA RSMKSS-EA RSMITRAKK-EA RSUPDr.Wahidin-EA RSUDPadangan-EA RSPSURABAYA6 PTSEJANU04 RSMITRA-EA RSUDProvinsiNTB-EA RSUDKOTADUMAI-EA RSUDKKM-EA RSOtak-EA RSUPM.DJAMIL-EA RSUDPalembang_EA RSUDSIJUNJUNG-EA MitraKeluargaJatiasih-EA RSUDPANDEGA-EA Not Available 81100EA001 tbc1 23674859 IL1469IT02 IL1098IT17 B5167325 A51043279 TBC B5368607 B5365906 A5123518 Not Available A5630614 A212223401 MAR-EA-PROD01 MAR-EA-PROD02 MAR-EA-PROD03 MAR-EA-TEST A5210805 20632714 Not Available 01454806 TBD A6085806 TBD A5103534 24429866 A5105199 A5188549 A670060228 A5156031 25152588 A5721909 A378444702 01762793 YP5025-Centricity Enterprise Archive-02166386 PV2009 PV2035 PV2016 PV2027 PV2041 PV1227 YP5018-Centricity Enterprise Archive-02040816 YP5040-Centricity Enterprise Archive-19983945 PV0846 PV2061 PV1065 PV1049 PV5011 YP5047-Centricity Enterprise Archive-20617591 YP5044-Centricity Enterprise Archive-20484084 YP5028-Centricity Enterprise Archive-02248294 YP5013-Centricity Enterprise Archive-18045998 PV0893 PV2034 PV2020 PV2021 PV0832 PV1042 PV2037 PV2038 PV2011 PV0894 PV2013 YP5031-Centricity Enterprise Archive-02332513 PV2014 PV1045 PV5020 YP5037-Centricity Enterprise Archive-15349246 PV2012 YP5021-Centricity Enterprise Archive-02183759 PV2008 YP5026-Centricity Enterprise Archive-02253243 YP5033-Centricity Enterprise Archive-02399307 PV2051 PV0892 PV1052 PV5022 YP5022-Centricity Enterprise Archive-02285740 PV2054 PV2055 PV5021 PV1035 PV2022 YP5034-Centricity Enterprise Archive-14194564 YP5038-Centricity Enterprise Archive-16450969 YP5045-Centricity Enterprise Archive-20509114 PV2053 PV0860 PV0903 PV1027 PV1051 PV2043 PV1061 YP5042-Centricity Enterprise Archive-20101282 YP5030-Centricity Enterprise Archive-02273408 PV0877 PV2028 PV0490 PV2026 YP5035-Centricity Enterprise Archive-15111124 PV1226 PV2025 PV2057 PV1062 PV1020 YP5048-Centricity Enterprise Archive-20644651 PV1064 PV2058 YP5039-Centricity Enterprise Archive-19630030 PV5010 YP5023-Centricity Enterprise Archive-02256895 PV2031 PV2015 PV0873 PV2052 YP5019-Centricity Enterprise Archive-02042637 YP5036-Centricity Enterprise Archive-15261449 PV2029 PV2007 0850550152 0850550196 0850550314 0850550115 0850550316 0850550321 0850550139 0850550238 0850550296 0850550298 082S129003 0850550249 0850550140 KW1155PC11 KW1157PC05 - RAD EA KW1163PC05 KW1102PC02 KW1011PC07 KW1012PC04 KW1155PC16 - CVIT EA KW1018PP03 KW1020PC01 KW1163PC07-CVIT EA KW1096PC04 KW1018PC21 KW1018PC16 KW1098PC01 KW1004PC03 KW1007WS06 KW1001PC09 KW1019PC02 - CVIT LB1485PC03 LB1001PC09 LB1160PC02 LB1000PC04 LB1462PC02 LB1497PC09 HUSM010 UMMC-EA4 CVSKL-EA TBA-EA_4448076_96 CENGILD-EA PSH-EA MMC8 MMC-EA-Shadow HSB-EA REGENCY-EA4 PKHS-EA Lifecare-EA Hospital Sultan Abdul Halim, Sungai Petani_EA Pahang Karak Health Clinic IIUM-EA AMPANG2 SERDANG2 Mediliance01 SGB-EA HPU-EA 01301460 HCIT4579183EA HCIT4753028EA HCIT4825663EA HCIT4865124EAnew HCIT4784198EALTS HCIT4784198EADB HCIT4753028EA HCIT4820102EA HCIT4665855EA HCIT4865124EA HCIT4753028EALTS AMS3961 ASS0160 Not Available To be defined To be defined To be defined To be defined To be defined To be defined To be defined To be defined To be defined OM1109PC07 OM1109PC06 HCIT5109010EA HCIT5109010EA2 HCIT4369313EA HCIT4714397EA HCIT1693543EALTS HCIT1693543EALTS2 HCIT1693543TESTEA HCIT1693543EAMIG HCIT4274455AEA backupGD2 AFFIDEA24838968 backupkal TBD AFFIDEA24840214 AFFIDEA25205462 PL1426PC01 TBD backupols Not Available AFFIDEA25205463 AFFIDEA24834222 AFFIDEA24839746 SiteID-Centricity Enterprise Archive-20571215 PL3277RW02 PL3249PC01 PL1674PC01 PL1943PC01 PL3192RW02 AFFIDEA22171731 SZASEROW24442162 TBC SiteID-Centricity Enterprise Archive-20094759 PL1644PC01 Not Available AFFIDEA20650372 AFFIDEA25205864 AFFIDEA24836050 AFFIDEA25205465 TBD PER50334 To be defined To be defined To be defined To be defined QA1102PP01 QA1015PP05 QA1015PP06 RODATBV-EA01 RU1934ID01 RU8902ID01 RU3152ID01 RF1194ID02 RF0048ID01 RU7645ID01 RU8776RW01 RU1011ID03 RU1648RW01 RU3453RW02 RU9617ID01 RU0472ID01 RU7361ID02 RU8356RW01 RU3232ID02 N/A RU1733ID01 RU3756ID02 RU2527RW01 RF3071ID01 RF3031ID02 RF1647ID03 RU7950ID01 RU1516ID01 RU8271ID01 RF0827ID01 RU1857ID02 RU8189ID02 RU9227ID01 RU9333ID01 RU1112ID03 RU1717ID03 RU1192RW01 RU2751RW01 Not Available RF2557ID01 RU7021ID02 RU1757ID01 RU3192ID01 RU2966ID01 RU1095ID02 RU3143ID05 RU3052ID02 RU9000ID03 Not Available Not Available Not Available Not Available Not Available RU1128ID01 RU6265ID02 RF1085ID02 RF1085ID04 RU9515ID01 RF1203ID02 RU2665ID02 RU3896ID02 RU3158ID01 Not Available Not Available 600101RW01 RU2050ID03 Not Available RF0001ID01 RF0001ID10 RU9594ID02 RU2636ID01 RU8615ID01 RU1377ID01 RU1052ID01 Not Available RU1026RW01 RU2526ID01 RU9940RW01 RU8412ID01 RU0994ID01 RF0929ID01 RU1473ID01 RU3468ID02 Not Available RU9383ID01 RF1383ID03 RU1140ID01 RU7834ID01 RF2412ID01 RU1143ID02 RU1449ID01 RF3761ID01 RU7579ID01 RU3427ID03 600105ID01 RU0968ID02 RU8796ID01 RU8782ID01 Not Available RU8151RW01 Not Available RU1152ID01 RU1999ID01 RU3998ID02 Not Available RU0912ID01 SA2591PP03 SA1060_CARD SA2410PP08 SA1039PP11 SA2433PP04 SA2385EA01 SA2329PP - EA LTA SA1005PPEA - CARD SA1005PP08 - RAD SA1176CCA SA1025EA SA2110_EA_LTA SA1209PP12 SA1008PP15_EA_PROD SA1008_EA_TEST SA1001_EA_PROD SA2191_EAGW SA2393EA01 SA2006PP06 SA1175 RADLINK12 Not Available TTSH-CVIS-EA-PROD To be defined U-1ERQRC20606142 ZA2103PP01 ZA2874PP01 ZA2241PAC5 ZA2812PAC6 ZA2151PAC4 ZA2917EA01 za000000 MPX43143 NE465132 NE465122 NE670337 NE670327 NE673148 NE673139 NE300618 NE219652 NE219646 NE219690 FEG51832 FEG51833 MEX70165 MEX25581 MEX689420 MEX689439 MEX689482 MEX689483 MEX689484 MEX689485 MEX617118 GPQ13905 DEN272119 DPN29615 DPN29616 DE993856 NPV73815 NPV73806 NPV73807 NE203154 NE203143 NE203144 NE740530 NE216236 NE216227 NE216228 NE487836 NE487828 FPD10808 FPD10831 DE5392100 DE539284 DE539293 Not Available NE723615 NEV07038 NEV44302 MED09301 NE748623 NE748616 NEV13629 NEV13620 YE645875 NEV06840 NEV06841 NE304916 NE419153 NPV84530 NE223257 NE223247 NE419142 NE419143 NPV84523 NPV84524 NEV439277 Not Available C99999302 NE741447 NE741439 NEV35828 NEV35829 NE688828 NE688829 UP285A31 GEE34099 tobecreated 150010EA01 475290PC04 Not Available 315258PC01 730140PC01 150080PC01 0853550820 0853550867 0853550142 0853550260 0853550871 0853550983 0853550804 0853551073 0853551073 0853550616 0853550993 0853550902 0853550869 0853550276 0853550993-Centricity Enterprise Archive-20680151 0853550201 0853550772 0853550218 0853550421 0853550000 RAMATHIBODI04 CHONBURI02 KKU-EA HCIT4783733EA 06051PAC09 06680PAC04 06162PAC02 06051PAC02 06002PAC31 06008PAC01 06002-CARDEA 34696PAC03 34365PAC01 34893PAC02 34361PAC02 34225PAC08 34412PAC02 34435PAC03 34433PAC02 34340PAC05 41400PAC04 48010PAC06 06004PAC26 59025PAC03 EA23.5 AE0002PP07 AE1802PP03 AE1564PP07 01888407 60638EA002 60116EA001 CRHCARDEA01 60044ARM02 tbc KGHCCWEA Not Available 80257RJF02 80257RJF01 RTGAIM30 EDLC_EA_Univ_Hosp_Leicester EDLC_EA_EMRAD_Kettering_General Not Available WSEA01 RBK0200101 Walsall24399361T HCIT5125353EA HCIT4210533EA HCIT4268589EA UZ1307ID01 BacLieuGH-EA BacLieuGH-NB-EA PhuongChauCanTho-EA VINMECDN09 THUCUCIGH01 VINMECHAIPHONG09 VINMECINT-EA VINMECTANCANG-EA CIH-EA VINMECNHATRANG09 VINMECPQ9 NINHBINH004 THANHNHAN03 NCH-EA SAIGONITO01 TDMEDICAL01 TDMEDICAL-EA XuyenACuChi-EA4 VINMECHL09
FEI Number 3004526608
Recalling Firm/
Manufacturer		 GE Healthcare
500 W Monroe St
Chicago IL 60661-3671
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your systems by following the instructions below. 1. Do not perform any new inbound data (DICOM) migration projects. Please contact GE HealthCare before starting any new migration projects. 2. If using Enterprise Archive with Core Services Hub/Workflow Core Services, when reviewing or exporting prior imaging studies after migration to Enterprise Archive, verify that the study and images within the study are associated with the correct patient as follows: At the Study level: " Compare name, date of birth, and patient identifiers only if burned-in or embedded in the image. Do not rely on patient information in the image overlays that can be toggled on and off. " If burned-in or embedded patient identifiers are not available, compare with prior studies based on patient anatomy, implants, or unique anatomical features. At the Image level: " Confirm that the images within the study do not belong to different patients based on acquisition date and time or other patient identifiers. Please maintain any previous source systems or migration servers pending correction of this issue by GE HealthCare. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions above. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 85492 Digital Response Form or print, fill out manually, scan, and email to recall.85492@gehealthcare.com. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce1856 systems
DistributionWorldwide - US Nationwide distribution.
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
510(K)s with Product Code = LLZ
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