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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity PACS

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 Class 2 Device Recall Centricity PACSsee related information
Date Initiated by FirmAugust 05, 2024
Date PostedSeptember 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3214-2024
Recall Event ID 95243
510(K)NumberK043415 K110875 
Product Classification System, image processing, radiological - Product Code LLZ
ProductGE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Code Information All versions of Centricity PACS: V2, UDI/DI Not Applicable; V3, UDI/DI Not Applicable; V4, UDI/DI 00840682124430; V6, UDI/DI 00840682104807; V7, UDI/DI 00840682145572 installed on the following systems: CARTI02312611, CARTI22214087T, 501268SSASW, 501268SSATSW, 928757VPASW, 928757VPBSW, 928757VPTSW, 602344PVSW2, 602344REPSITEB, MARICOPAC02308029, 602344TIMSVM, 480323PVSW, 661633PVSW, 805395PVSW, 805395PVTSW, V5SPORTS01804913, 310349PACSSWPV, UCLAMC2259090, 310349PACSSWBPV, UCLAMC2259063, 831624PVASW, UHSD02184496, 916781CPACSSRWT, PALMDALEM01810792, PALMDALEM16023955, UHSD16084343, PALMDALEM20508297, PALMDALEM21178954, MHL02186470, 909788HCAPACS1, 916781CPACSCKS, 916781CPACSBCKS, 650696PACSEESW, MPHS2259091, GSHCACPSW, GSH320037250, VSMY01820423, 209532SESW, SONORAREG19607823, RANCHO02255039, RANCHOPISU2, RANCHOPTESTISU, To be Provided , 805370HCALR, VMPACS69, LOSROBLES19666790, SOUTHWEST01815383, MCANPACSW, MCASPACSW, CENPACSW, 303329HCAPSWS, 303584HCAPVSW, 303584REPBSW, 303584HCAPVSWTESTIMS, SRMCPACSW, 719584VPSW, PKV2259020, 719584VPBSW, NSMCPACSW, 970476PVSW, VVMC15111181, 302674PACSSW, 302674PACSBSW, 302736SAEATSW, JFKSW, JFKR19980220B, INFINITYW01452121, 727462PVSW, 727462PVBSW, MPMH2259089T, 772461HCAPACSW, 772461HCAPACSW1, 772461HCAPACSWT, FWMCCPTSW, 352333PACSSW, NFRH19663978B, 904202BMCDSW, 904202BMCSSW, MJPACSW, MJPACTSW, 904202BMCDTSW, BIHT20915070-IMSTest2, BIHT20915071-IMSTEST4x, 407518COREPACS, HH1001398036, 407518CPREPB, 863680PVSW, KRMCOREPACSSW, KRMC19478073, 407888HCASWSS, 615344HCASW, PCMC420084442, 561694CAPACSSW, WFLHIV01, WESTFLORI19661467, 772335PACSSW, 772335PVSW, 941637PVSW, 941637TIMS90, 850875PVSW2, 904819PVSW, 904819PV2SW, 904819PVTSW, 727519PVBSW, 850325PACSCORE, CRMC820084433, 888663CPBSW, USFIMSSSASW, 727519PVSW, VSMAE01817090, NGDC01893569, 888663CPTSW, 888663CPB2SW, USFIMSSSABSW, USFIMSSSATSW1, USFIMSSSATSW2, 727519PVMSW, 727519PVTSW, VAMAF02345966, VSMI18957442DCC, 407518SCPACSHC, 850325HCASWOPT, WFLHIVT01, PCMC42259036, 352333PACSTSW, VSMAM02004646, WELLINGTON01810730, UHSD02289750, WELLINGTON19678279T, WELLINGTON20036598, TRMPACSW, TRMNC20021605, 100115-8-Centricity PACS-21222171, TRMTESTPACS, Doctors Ho22222417, 407772CORESW, 404605PVBSW, 404851PVSW, 404851PVTSW, 404851PVBSW, 404605PVTSW, 407772COREBSW, 407772CORETSW, 706651HCACORE, 912466PVSW, SGHS2259039, 912276PVSW, 912276PVTSW, 706278PACSSWPV, 706278PACSSWBPV, 706278PACSSWTPV, 404501PACSSWPV, 404501PACSSWBPV, 404501PACSSWATPV, 404501PACSSWBTPV, 706754PACSSW, 404605PVSW, 478633PACSSWPV, MCG2259011, MCG20084728, VSMQL01987331, 404325PACSSWPV, 404325PACSSWBPV, 404325PACSTSW, 406238PVSW, VSMZ01812192, 641422PVSW, PROSPECT2259057, PROSPECT2259084, PROSPECT22128566, 319272SCPSWULP, 319272CPDRSW, 319272CPDRBSW, 319272SCPTSWULP, 208COREPVSW, EID19660790, 208CORETIMS, 208743PVSW, 208743PVTSW, 847NWCPVSW, 847NWCPVSW2, 773880PVSW, 795079PACSEESW1, 795079PACSEESW2, 312926PACSSWPV, 312996PVSW2, JSHPACSSW, 312996PVSW1, 312996PVSWT1, 312996PVSWT2, 795079PACST, JHSJHOCC02259030, 773880PVBSW, 773880PVTSW, JSHPACSTSW, 217876PVSW, 217876PVBSW, 815285PACUV100, 630963PVSW, ADVPACSTSW1, 847437PVSW, 847437DCPVSW, 847437SAPVTSW, 847990PVSW, S046PACSSWPV, S801PACSSWPV, S046PACSSWTPV, ADVPACSSW, ADVPACSBSW, ADVPACSTSW, 815398CPACSSW, 219325PVSW1, 219325PVBSW1, 219325PVTSW1, 765983PVSW, 765983PVSW2, RHHCS02253964T, 812232PACSPV, 812232PACSTPV, 812232PACS2PV, THRH20084364, FRNKHAPACSPV, FRNKHAPACSTPV, FRANKFORT19633100, RRMCPACSW, RGMCPACSTW, RRMC120080697, VTP01810617T, VHT02334235P, VTP19617532, 985867CORESW, 985230PVSW, NOMC2259032, CFO18227240, 985230PVSWS, 504903CPACSSW, 504988SSASW, 504903CPACSTSW, 504988SSATSW, MCOLANO20039031, HTMC20085961, 504903CPACSIMS, 617638SSASW, 617638SSBSW, 617638SSATSW, 781979PVSW, 781979PVBSW, 781979PVTSW, 413447BCPVSW, 413447HCPVSW, 413447PVSW, 413748PVSW, 413748PVTSW, 413748PVBSW, 301698PVSW, 301698PVTSW, NORTHE02315652, NORTHE02370307T, 207795PVSWC3, 207795PVSWC1, 207795PVSWC2, 517353PACSEESW, 517353PACSEETSW, 906387VPSW, 248858PVASW, 248858PVBSW, 248858PVTSW, 906358PACUV100, 507288PVSW, 507288PVSWT, OMCR19625746, 651855PVSW, 651855PVBSW, 612831PVTSW, 660885PVSW, 660885PVTSW, S011PACSSWPV, S011PACSBSW, S011PACSTSW, 417623PVSW, 417623PVTSW, 417623PVBSW, BARTONCOU01819621, S009PACSSWPV, S009PACSSWBPV, S009PACSSWTPV1, S009PACSSWTPV2, 601824PVSW, 601859PVSW, MCMC2259045T, 601200PACSEESW, 601200PACSSWPV, 601376PVSW, 601936PACSSWPV, SDJM20032054, 601883PVSW, 601883PVTSW, DBCSW, 406345SCPACSTSW, 828326PVSW, 704660PVSW, 704660PVTSW, 402484PACSSW, AMIM02031832, 603433TSW1, 603433SW, PRH119666811, 609652PACSSW, 609652PACSBSW, 609652PACSTSW, 609835PACSSWPV, 609835PACSTSW, 609835PACSSWBPV, VHGPVSW, VHGPVBSW, VHGPVTSW, 856342CPACSSW, 856342CPACSBSW, 856342CPACSTSW, 973490PVSW, 973490PVTSW2, 973490PVTSW1, UMDNJPVPSW, UMDNJPVPBSW, UMDNJPVPTSW, 609383UVPACS100, 908522PVSW2, ARTHRITIS01452981, 505609PVSW, SJRMIMST20655929, 702733CPACSSW, SHPACSW, SUNPACSW, VALLEYHEA14460287, SUNPACSREPB, 20910879CPACST, NORTHERNN20284710, NORTHERNN20838223, NORTHERNN20838225, BLH01442255TST, BLH01451970, STO01440342, STO02157029, STO02157030T2, 718206PVSW, 718206PVTSW, 2435-1-Centricity PACS-20608371, 718206REPBSW, 315798PVSW1, 315798PTISU, COLPVPSWIMSA, MSKPVSW, MTSPACSSW, NEWYORK01976546, VSMAT01986937, MSI02099022, COLPVPSWIMSB, COLPVPSWIMSAT, COLPVPSWIMSBT, MSKPVBSW, MSKPVTSW2, MSKPVTSW3, MTSPACSBSW, ERM16295285, MSI19614991, 718920PVSW, 718920PVTSW1, BROOKHAVEN15531196, OAR01373900, 516763PVSW, 516763PVBSW, 516763PVTSW1, 516763PVTSW2, STO18806599, 914357PVSW, GSHP01370055, 914357PVBSW, 914357PVTSW, 315470CPACSASW, 315470CPACSBSW, 315470CPACSTSW, CRH21306236, 914681PVSW, 914681PVTSW, 718920PVYSW, 718920PVTSW2, 330543PACSSWPV, CHPA2259061, CHPA2259088T, 513747PVSW, 614234PVSW, 614722PVSW, MARKHZAN01465406, 614722PVBSW, SAH52259083, SAH52259110T, 614722PVTSW, 740348PACSSW, 740348PACSBSW, 740348PACSTSW, 419383PVSW, MUOO2259017, 419383PVSWB, STMARYS-TISU, STMARYS-PISU, S040PACSSWBPV, S040PACSSWAPV, S040PACSSWTPV, 503257PACSSWPV, UHS101383446, PAMC19604625T, TMGSSASW, 215913CPBSW, 484526PVSW1, 484526PVTSW, 484526CPREPB, 215710PVSW, SMMC14898807, QUANTUMIM14640640A, QUANTUMIM14776702B, QUANTUMIM14776726T, 570523PVSW, EVAN02302786T, EVCH22176253, EVANVTPACSIMS, 724728SSASW, 724728SSABSW, 724728SSATSW2, STMARYME01476581, 412575CPACSSW, 412623CPBSW, UHS100555969, UHS101404909, 412623CPTSW, 215453PACSSWPV, GVH102398920T, GVH121323962, 401444PVBSW, 401444PVSW, 401444PVTSW, AIMC01810707, AIMC19632995, 864716PACSSWPV, 864716PACSSWT, 864716PACSSWBPV, TRMT2PACSW, 803461PACSSWPV, SCOA2259023, 843347PVSW, 843347PVTSW, CNOS02186078, 605353SSASW, 605333PVSW, 605882PVSW, 423493PACSW, 423553VPSW, 423855PACSW, 423493REPB, WTN00104692T, WTN2259070, WTN2259097, WTN21176121, 423837HCASWSU, 423431PVSW, 865977SSASW, 865977SSTSW, 806354CPACS, 806354CPACSB, NORTHWEST21314320, 806354CPACST7, 361694VPSW, DRISCOLLC02257225TIMS, 214820EEPVSW1, BSWNPACIMSDB1TR, SCW2259068, FORTDUNCA01810773, FORTDUNCA20854738T, FORTDUNCA21337445, DSMCCOREPACSSW, DSMCCOREPACSDRSW, DSMC-22886533, 214820PVSW, 972906GSPACSSW, HCA-NORT02332691, MEDIC01812756, 281274MSLPVSW, 713441MHPVSWA, 713704MHMSWA, 713704MHMSWB, 713704MHMSWTA, 713704MHMSWTB, 713741MHHPVSWB, VSMHE01893552, DHOL01810756, DHOL15291375T, DHOL20631410, DHOL23253841, 713770CVPACS, 210670PACSSWPV1, 254918PACSUV100, 214820EEPVSW2, BSWNPACIMSDB2T1, 254724PVSW, SCW2259095, VASOY02315718, 361572SSASW, CMDC2259015, HH1001979502, 801DASSW, 801DSWSP1, 801377PVSW1, 801SOFTWARE, 801SOFTWAREOPT, SMH820071869, 801924HCADASSW, MNTSW, 434654PVSW, APICPAX1CS07, 540433PVSW, CFHCAPACSW, RHC123290092, CMCPACSW, 352867PACSSW, HDHPACSW, CMCPACSTW, FHS219676614, CH721013826, CH721013832T, LGMSW, LGHI20084372, LGMSWOPT, RESTRAPVSW, RHC120038618, STSP21736781, STSP22125863, 802775SSASW, 802775SSATSW, 802775SSATSW4X, KVCH01462777, 206292PACSSWPV, 206292PACSSWTPV, 206364PVSW, 206545EESW, 206364PVBSW, UWTDB101, UWH20021873REPB, UWTDB110, 414465PVSW, 414465PVTASW, 414465PVTBSW, 414465PVBSW, PCHT01721604, 608745PVSW, COMMUNITY01973590, 304487PVSW, PCH12259035-TISU, 304536UVSW, DZ1906PP02, DZ1381PP01, DZ27??PP03, DZ2112CC01, To be Provided , To be Provided , To be Provided , HCIT4691855CPACS, HCIT1555339PACS, HCIT4825134PACS, HCIT1524287PACS, HCIT4691855PACS, HCIT1596840PACS, HCIT4430774CPACS, HCIT5184728CPACS, HCIT4859945PACS, 0910620047, 0910620047, 0910620047, 0910552308, 0910552310, 0910553037, 0910553037, ANZVICCAUL, ANZVICSAND, AH0104CS01, AH5045CS01, BH1038PC01, 22303605, To be Provided , 130041ST02, 030151ST09, 010120ST03, 010120ST52, 300013ST04, 300013ST09, 300013ST11, 300013ST21, 300013ST24, 441236VPSW, VSMAI01812924, HCIT4691866CPACS, HCIT4759526PACS, HCIT7102800PACS, HCIT7125379CPACS, To be Provided , HCIT5245250CPACS, HCIT5245250CPACS, HCIT4860936PACS, HCIT4432783PACS, HCIT5317135CPACS, HCIT4290686PACS, HCIT5245275CPACS, 323782-Centricity PACS-21288445, HCIT4790060PACS, HCIT4769017PACS, HCIT7203852PACS, HCIT4478566PACS, HCIT7134190CPACS, HCIT4568867PACS, HCIT7104315PACS, HCIT7103264IMS, 656687-Centricity PACS-21288460, HCIT5273606CPACS, HCIT5245248CPACS, HCIT5245248TESTCPACS, HCIT7229698PACS, 604520REPSITEA, 604520GEPACS, 604520TESTIMS, 604586REPSITEB, 709737PACS, 709752CORDMODA, 709752IMSAsw, 709752IMSBsw, 709752ITS1A, 709752ITS2B, 709752REPSRVRAsw, 709752GEPACS, 709752DCSDAS02sw, 709752DCSDAS04sw, 709752TESTIMSsw, 709752DASTST01sw, 709737DASEHOUTsw, 709752REPSERVERsw, 709752DCSDAS01sw, 709752DCSDAS03sw, 709752TDASNL01, 709752TDASNL02, 709752DASNLA01, 709752DASNLA02, 709752DASNLA03, 709752DASNLA04, 709752DASNLA05, 709752DASNLA06, 709752DASNLA07, 709752DASNLA08, 709752DASNLA09, 709752DASNLA10, 709752DASNLA11, 709752DASNLA12, 709752DASNLA13, 709752DASNLA14, 709752DASNLA15, 709752DASNLA16, 709752DASNLB01, 709752DASNLB02, 709752DASNLB03, 709752DASNLB04, 709752DASNLB05, 709752DASNLB06, 709752DASNLB07, 709752DASNLB07, 709752DASNLB08, 709752DASNLB09, 709752DASNLB10, 709752DASNLB11, 709752DASNLB12, 709752DASNLB13, 709752DASNLB14, 709752DASNLB15, 709752DASNLB16, 709737UTILITYsw, 709752ITS2sw, 709752ITS1sw, 709752CORDMODsw, 709752DASTST02sw, 709637DAS01sw, 709637DAS02sw, 709637DAS03sw, 709637DAS04sw, 709637DAS05sw, 709637DAS06sw, 709637DAS07sw, 709637DAS09sw, 709637DASWH10sw, 709637DASWH11sw, 709637DASWH12sw, 709637DAS10sw, 709637DAS8sw, 709637DAS11sw, 709637DAS12sw, 709637DAS13sw, 709637UTILITYsw, 709637CDPSsw, 709651DASGA01, 709651DASGA02, 709651DASGA03, 709651DAS01sw, 709651DAS02sw, 709651DAS03sw, 709651UTILITYsw, 709292DAS01sw, 709292DAS02sw, 709292DAS03sw, 709292DAS04sw, 709292UTILITYsw, 709292PACS, 709454PACS, 519843IMS, 519843TESTIMS, 519843GEPACS, 905522GEPACS, 905521GEPACS, 905521IMSA, 905522IMSB, 905521TESTIMS, 613548IMSA, 613548IMSB, 613548TESTIMS, 613548GEPACS, 519685REFERENCEIMS, 519685REFERENCEDAS, 905575IMS, 905576REPSITEA, 905576REPSITEB, 905576GEPACS, 905576TESTIMS, 613732GEPACS, 613732IMS, 613732TESTIMS, 519426IMS, 519426TESTIMS, 519426GEPACS, 416813REPSITEB, 416813REPSITEA, 416813TESTIMS, 416813GEPACS, 416326IMS1, 416326IMS2, 416326GEPACS, 416756GEPACS, 416756TESTIMS, 416756IMS, 905372GEPACS, 905372IMSA, 905372IMSB, 905372TESTIMS, HCIT4602438PACS, HCIT4358052PACS, HCIT4949579PACS, HCIT4920063PACS, HCIT4096494PACS, HCIT4567313PACS, HCIT4601968PACS, HCIT5026141PACS, HCIT5183890CPACS, HCIT4888543PACS, To be Provided , To be Provided , To be Provided , To be Provided , 082499110172, 082499310155, 082455210055, 082455150052, 082455150052, 082455160221, 082455160221, 082455160134, 082499180109, 082499180102, 082455160255, 082427190180, 082445110005, 082403010015, 082455190146, 082499130790, 082499130125, 082499130790, 082499020074, 082455040339, 082407040684, 082407040684, 082455040204, 82455040334, 082499040230, 082455040337, 082455040339, 082455040147, 082455040274, 082455040352, 082445040028, 082445040028, 082455040317, SiteID-Centricity PACS-20608297, 082407040684, 082499110183, 082455190147, 82499220115, 082499100382, 082455150074, 082455150068, 082455150039, To be Provided , 082455180040.082499180080, 4807212, 082455170088, 082499010124, 082499110172, 082499060054, 082499100386, 082499100386, 082499100386, 082499100386, 082455100286, 082499250135, 082499250042, 082455070037, 082455120548, 082455120548, 082455100352, 082455100179, 082455100179, 082455160241, 082455200034, 082433120225, 082499120374, 082455120507, 082499250135, 082455180041, 082455120545, 082455120552, 082455120510, 082499100188, 082499100188, SiteID-Centricity PACS-20595026, To be Provided , 082455130065, 082455130335, 82455290014, 082499130780, 082455130366, 082455130394, 082455290015, 082499180085, 082445030013, 082455160035, 082499180106, 082499130792, 082455120226, 082455080025, 082455050079, 082455050076, 082455050069, 082455120371, 082455130415, 082427150109, 082455060004, 082455120544, 13767625-Centricity PACS-21273767, 082499130816, 082499130826, 082407120583, 082455100357, 082407100616, 082499100385, 082455100353, 082499100415, 082499230063, 082499260011, 082499140323, HCIT4825460CPACS, 2939580-Centricity PACS-21294025, HCIT5231090CPACS, HCIT4668793PACS, HCIT50000107PACS, HCIT1516613IW, HCIT1543321PACS, HCIT4946501PACS, 40549-1CP01, 40549-1CP01, DK9022PAC1, DK9154CA01, DK9066IMS1, DK9066TESTPAC1, HCIT4277575PACS, HCIT4692615PACS, HCIT4796839PACS, EG1526PP02, EG1017PP02, EG1055PC01, HCIT5162696CPACS, ZA2879PP01, M4477025, X129763408, A4167665, 22106615, A4498636, M61421909, M100323902, M2030921, M2753440, M4171826, M4476437, M2001113, X59655539, To be Provided , M4206540, M5172536, M5172537, M5172568, P4172826, P4172827, M178185410, X387005305, MQ1234502, M386578303, A27411, M4144112, M4045536, M4046544, M4047061, M40480163, M4188439, B4191728, C4191734, D4191718, E4191720, M54807112, NC1028, To be Provided , To be Provided , M4491536, PF1000PC02, M143153109, M4143924, M4143984, M220995201, 02398902, M4825009 / M4825010 / M4825011, M4204530, H4858984, D4858905, D4858906, D4858918, M838835602, M9164747, M4209925, M4209926, M4209927, Utuora, HNO, M4505229, HC0399PA01, HC2641CS01, tobecreated, 530019CS01, PC0075CS01, tobecreated, 744459PA02, HC0220CS01, 518086CS01, HC2720CS02, HC4017CS01, HC0074CS01, HC1627CS01, HC4438CS01, HC0881CS01, UC2847CS01, UESS01CS01, 126292CS01, UJJF01CS01, 416005CS01, HC4912CS01, 530366PC03, UC1220CS01, HC0468CS02, 556162CS01, UHAM02CS02, HC0727CS01, tobecreated, UHAN01CS01, 362520SV01, HHAN01SV01, HHEI01CS01, HHEI02CS01, UC1989CS01, HC7048CS02, 410014SV02, HC1992CS01, HC1282CS01, HC2554CS01, tobecreated, HC0847CS01, HC3019SV03, 624751CS01, HC0014CS01, To be Provided , HC1467PA01, 560496CS01, 145774CS01, HCNE01CS01, HC0094CS01, 553160CS01, 434487CS01, HCSC01CS01, HC3076CS01, UC4372SV02, HC0863CS01, 424881PA01, GH1069PP01, GH1022PAC1, HCIT4494109PACS, HCIT4494109UV, HCIT523983PACS, 828550053, 0828550074, 0828550085, 0828550070, 828550079, 0828550105, 0828550072, 828550052IB01, 828550064, 828550066, 828550052IB01, 828550095, 0828550073, 828550057, 083055283270418, 083055247345516, MAX-DC-PACS, 083055820666618, MCCT-CPACS, 083055863242715, 083055868428111, SCTIMST-IN-CPACS, RCC - CPCS 7.0.0.4.8, 083055201766451, 083055204252715, Wockhardt-CPACS7.0.0.4.8, INHS-ASWINI-CPACS, 083055207081618, AIIMS-NM-PACS, 083055003435816, SIRHNHOSPITALTRUST-CPACS, 083055211206517, QUALITYCARE01, 083055803467916, 083055801005510, 083055806995816, 083055801058716, JIPMER01820558, 083055808240917, NARUVI -CPACS, 083055840003710, CHL-CPACS-6.0.10.3, 083055604732915_CPACS, RSUDMadaniPalu-CPACS, PTUROGEN01, MayapadaBandung-CPACS, TEASIAHEALTHCARE-CPACS, PTGLOBALMP-CPACS, PTMKMas02, PTSentosa1, SiteID-Centricity PACS-20535377, SANTOSA-CPACS, MKCikarang-CPACS, MKBekasiBarat-CPACS, MKBEKASITIMUR_CPACS, MITRADEPOK001, RSUDTarakan-CPACS, RSUDSlawi-CPACS, RSUDTarakanKaltara-CPACS, PTMULYA-PACS, RSReginaMaris-CPACS, RSUDKlungkung-CPACS, RSPBINTARO2, RSMKG-SERPONG01, MITRAKELUARGATEGAL-CPACS, RSUDKabupatenB-CPACS, RSUDMukomuko-CPACS, RSUDCIAWI-CPACS, RSUDPadangan-CPACS, RSPOLRIB-CPACS, RSMITRAKD-CPACS, PTUNISIAMEDIKAFARMA_CPACS, RSMK-KelapaGading01, RSUPFATMAWATI-CPACS, RSKELUARGAKALIDERES-CPACS, RSHARAPANKITA-CPACS, RSPJATINNEGARA1, PREBO001, SULIANTI001, MitraKeluargaSlawi-CPACS, RSMKKEMAYORAN-CPACS, RSMK-Cibubur01, RSUDPandanArang-CPACS, RSMardiRahayu-CPACS, RSALDr.Ramelan-CPACS, RSUDKKM-CPACS, RSUDPasirian-CPACS, RSUDProvinsiNTB-CPACS, RSHajiSurabaya-CPACS, RSUDBHAKTIDHARMAHUSADA-CPACS, RSPHCSurabaya-CPACS, RSJDSurakarta-CPACS, RSUDSOREANG-CPACS, RSUDDRHKB-CPACS, RSUDHMB-CPACS, RSDDRSJ-CPACS, RSUPSOERADJI-CPACS, RSUDDRMAP-CPACS, Dr.MOHAMMADZYN_CPACS, RSUDAMDS-CPACS, MitraKeluargaDeltamas-CPACS, RSUDBEKASI-CPACS, RSUPM.DJAMIL-CPACS, RSUDPalembang_CPACS, RSMITRAKK-CPACS, RSMITRAKELUARGABINTARO-CPACS, RSUDSIJUNJUNG-CPACS, RSUDBERKAHP-CPACS, RSUDPANDEGA-CPACS, RSUDMThDjamanS-CPACS, RSUPKARIADI-CPACS, RSUDKRMTW-CPACS, Sidoarjo-SysID, RSUDSidoarjo-CPACS, RSMITRAKW-CPACS, RSUDTuban-CPACS, SYAMSUDIN001, RSPSURABAYA1, RSUPDr.Wahidin-CPACS, HoesinPALEMBANG-CPACS, PTSEJANU01, BETHSAIDA-CPACS, MitraKeluargaPamulang-CPACS, RSUDLeimina-CPACS, RSUDWALED-CPACS, RSMITRA-CPACS, PTHNU02, KeluargaGrandWisata-CPACS, RSMKSS-CPACS, MitraKeluargaJatiasih-CPACS, RSBinaHusadaCibinong-CPACS, IQ1906PC03, IQ1727PC03, 81100DAS05, IL1018IT01, IL1059IT01, To be Provided , IL1484IT01, IL1469IT08, IL1098IT10, IL1098IT18, To be Provided , TBA, D5104305, B5104381, A51043144, A5802803, C5368613, A5368605, A5801809, B5368603, A5630621, A5121809, TBA, tbc, A5353013, TBA, A5660044, 02172341, A5768722, A5643504, A6085807, TBA, A5105147, A670060230, A5156018, A5119431, A5719805, C5603910, A5684351, to be created, 02286983, B5105141, A5145726, A5113125, HCIT4293918PACS, JD1102, YP1016-Centricity PACS-20584816, YP5025-Centricity PACS-02170316, JA0842, JL1419, JL1421, JD1260, JD1259, JD1258, JD1256, JD1257, JL1703, JA0896, JD1113, JA0738, YP4000-Centricity PACS-02321044, JL1701, JD1247, JD1246, JD1245, JD1248, JD1249, JA0894, JL1741, JD1276, JD1278, JD1279, JD1280, JL1718, JDS038, JDS039, JDS040, JDS041, JAS010, JL1387, JD0981, JD0982, JD0983, JD0984, JD0985, JA0734, YP5020-Centricity PACS-02097541, JDS003, YP5013-Centricity PACS-18045997, JL1702, JD1250, JD1252, JD1254, JD1253, JD1255, JA0895, JD1251, JDS022, JDS023, JDS024, JDS025, JL1160, JD1168, JL1728, JAS024, JDS087, JDS088, JDS089, JDS090, JDS091, JDS092, JDS093, JL1745, YP5037-Centricity PACS-15349241, JDS058, JDS059, JL1412, JL1408, JL1733, YP5022-Centricity PACS-02285739, JDS033, JDS034, JL1460, JA0750, JD1181, JD1182, JD1183, JD1184, JD1185, JD1186, YP5049-Centricity PACS-20978976, YP5030-Centricity PACS-02274229, JDS032, JL1750, YP4011-Centricity PACS-20584824, YP1017-Centricity PACS-02344060, JL1399, JL1732, JDS123, YP5009-JP-532345-Centricity PACS-20574025, YP4002-Centricity PACS-14539502, JL1168, JD0828, JAS022, JDS082, JDS083, JL1719, JL1144, JDS101, JDS102, YP5042-Centricity PACS-20101281, YP5031-Centricity PACS-02332510, JDS042, JL1396, JL1738, JL1290, JD1100, YP1012-Centricity PACS-20584811, JL1152, JL1721, JDS062, JDS063, JDS064, JAS017, JD1116, YP4001-JP-407999-Centricity PACS-19736997, JL1730, JDS111, JL1420, JD1081, JD1082, JD1095, JD1096, JD1097, JD1098, JA0830, JL1148, JDS001, JAS001, JDS002, YP5012-JP-100014-Centricity PACS-20574034, JL1407, JD1065, JD1069, JD1068, JD1066, JL1739, JD0959, JL1712, JA0900, JD1271, JD1272, JD1273, YP1014-Centricity PACS-01978327, JL1747, JD1099, JD1101, YP1013-Centricity PACS-20584812, JL1102, JL1413, JD1148, JD1138, JD1140, JD1146, JD1147, JD1139, JA0831, JD1150, JD1153, JD1159, YP5002-JP-341108-Centricity PACS-20568516, YP4006-Centricity PACS-20584822, JL1740, JL1748, JL1161, JD0767, JD0810, JD0811, JA0288, YP5048-Centricity PACS-20644650, JDS146, JL1736, YP5034-Centricity PACS-14194563, JDS047, YP5039-Centricity PACS-19629898, JAS016, JDS061, JL1417, JA0835, JD1187, JD1188, JD1189, JD1190, YP5027-Centricity PACS-02255460, JDS019, JDS020, YP5032-Centricity PACS-02360541, JDS006, YP5014-JP-280363-Centricity PACS-20574036, JL1752, JD1152, JD1151, YP1020-Centricity PACS-20584818, JL1753, YP5038-Centricity PACS-16450968, JA0834, JD1177, JD1176, JD1178, JD1179, YP5007-JP-280203-Centricity PACS-20574023, YP5004-JP-080362-Centricity PACS-20568519, JL1754, JA0832, JD1164, JD1165, JD1166, YP4012-JP-080218-Centricity PACS-20579603, JL1743, JD1091, JD1092, JD1093, JD1094, YP1011-JP-081007-Centricity PACS-20579601, JD1160, JD1167, YP5003-JP-080145-Centricity PACS-20568518, JL1751, JD1051, JD1052, JL1601-Centricity PACS-20584807, YP5024-Centricity PACS-02179873, JDS010, JDS011, JAS002, YP5010-JP-143756-Centricity PACS-20574031, JL1392, JD0999, YP5023-Centricity PACS-02256894, JAS006, JDS026, JDS027, JL1401, JD1013, JL1724, JAS020, JDS073, JDS074, JDS075, JDS076, JL1450, JD1143, JD1141, JD1145, JD1142, JD1144, JA0829, JL1746, JDS012, JDS013, JAS003, JDS031, YP5021-JP-240130-Centricity PACS-20574046, YP5001-JP-040967-Centricity PACS-20568514, JL1744, JDS021, JL1715, JAS007, JDS028, JDS029, JDS030, JL1726, JAS023, JDS084, JDS085, JD1169, JD1170, YP5006-JP-040008-Centricity PACS-20568522, JA0741, JD1161, JD1162, JD1163, JL1416, JL1720, JAS013, JDS052, JDS053, JDS054, JDS055, YP5035-Centricity PACS-15111123, JL1173, JL1390, JD0256, JD0257, JD0258, JD0259, JD0260, JD0261, JD0995, JD0993, JD0992, JD0991, JD0994, JA0301, JAS015, JL1734, JDS134, JDS135, JDS136, JDS137, JAS031, JL1737, JDS154, JA0899, JD1268, JD1269, JD1270, JL1705, JL1146, JD0774, JD0775, JD0962, JD1128, JD1125, JD1126, JD1127, JD0961, JL1710, JD1261, JD1262, JD1263, JA0901, YP5019-Centricity PACS-02042638, JL1749, JD1154, YP5000-Centricity PACS-02277426, YP5036-Centricity PACS-15261448, JDS056, JDS057, JD1130, JD1136, JD1137, JA0740, YP4004-Centricity PACS-20584821, YP5050-Centricity PACS-21180376, JL1742, JL1440, JD1121, JD1124, JDS105, JL1731, JL1159, JD0812, JL1723, JAS019, JDS069, JDS070, JDS071, JDS072, JD1149, JD1277, YP4005-JP-110249-Centricity PACS-20535391, JL1405, JD1057, JL1141, YP5026-Centricity PACS-02253241, JDS017, JDS018, JAS005, YP5033-Centricity PACS-02399305, JAS011, JDS044, JDS045, JDS046, JD1119, JD1120, YP4003-Centricity PACS-02276197, JDS004, YP5015-JP-221077-Centricity PACS-20574038, JL1704, JAS004, JDS014, JDS015, JDS016, JD1275, YP5018-Centricity PACS-02013203, JL1722, JAS018, JDS065, JDS066, JDS067, JDS068, JL1158, JD0978, JD0971, JD0973, JD0974, JD0976, JD0977, JD0972, JD0975, JA0736, JL1713, JAS056, YP1005-Centricity PACS-17452182, JL1391, JD0990, JD1061, JD0989, YP1004-Centricity PACS-20584809, JL1153, JD0784, JL1397, JL1393, JD1041, JD1015, JD1016, JDS133, JL1163, JL1418, JL1706, YP5044-Centricity PACS-20484083, JAS027, YP5005-JP-134658-Centricity PACS-20568520, JL1394, JL1386, JL1411, JD1017, JD0967, JD0968, JD0969, JD1108, JD1107, JD1109, JD0966, JA0733, JDS060, YP5028-Centricity PACS-02248290, JL1174, JD0839, JD0858, JA0290, JL1725, JAS021, JDS077, JDS078, JDS079, JDS080, JDS081, YP5011-Centricity PACS-02178701, JDS124, YP5046-Centricity PACS-20578187, JL1729, JAS025, JDS094, JDS095, JDS096, JDS097, JL1180, JAS026, JDS099, JDS100, JA0897, JD1264, JD1265, YP5016-JP-130422-Centricity PACS-20574042, JL1169, JD1267, YP5017-JP-160102-Centricity PACS-20574044, JD1050, JD1062, JDS112, JDS113, YP5045-Centricity PACS-20509113, JL1430, JD1071, YP1006-Centricity PACS-02309861, JL1735, JL1717, JAS009, JDS035, JDS036, JDS037, JDS043, KE2701CP01, KE0802CP01, KE0402CP01, KE1402PAC01, KE1110CP01, KE2001CP01, KE2202CP01, KE0301CP01, KE0202CP01, KE4705CP01, KE1502CP01, KE0201CP01, KE1602CP01, KE1701CP01, KE0302CP01, KE1111CP01, KE1201CP01, KE4701CP01, KE3004CP01, KE4704CP01, KE4601CP01, KE4101CP01, KE3402CP01, KE0601CP01, KE0702CP01, 0850550196, 0850550301, 0850550115, 0850550306, 0850550300, 0850550322, 0850550321, 0850550296, To be Provided , 0850550139, 0850550238, 852004_RAD-Centricity PACS-20542654, KW1190PC03, KW1011PC04, KW1018PP01, KW1147WS01, KW1155PC09, KW1155PC02, KW1102PC02, KW116PC06, KW1005PC01, KW1012PC01, KW1003-CPACSv7, KW1007PP02, KW1004PC02, KW1019SAHP, KW1013PC04, KW1001PC06, KW1096PC01, KW1019SAHP, KW1093PC03, LB1160SV01, LB1439PC02, LB1462PC01, LB1000PC01, LB1279PC02, LB1485PC01, LB1001PC04, LB1497PC04, To be Provided , MMC2, AMPANG6, IPPT4, SERDANG1, UTAR-CPACS, HSB-CPACS, HUSM008, UMMC-CPACS7, HPU-CPACS, IIUM-CPACS, REGENCY-CPACS, PSH-CPACS7, UNIMAS-CPACS, SGB-CPACS, PKHS-CPACS, Lifecare-CPACS, MSU-MY-PACS, Hospital Sultan Abdul Halim, Sungai Petani, SERDANG1, LIFECARE6, BMALTA25, MT1014PC01, HCIT4579183PACS, HCIT4665855PACS, HCIT4376494PACS, To be Provided , HCIT4550532PACS, HCIT4825663CPACS, HCIT4825663DAS, To be Provided , HCIT4784198PACS, HCIT4753028CPACS, HCIT4429184PACS, HCIT4820102PACS-SPS, HCIT4820102PACS, HCIT4865124PACS-IMS, HCIT4753028CPACS, AMS3960, OM1109PC01, OM1181PC01, To be Provided , HCIT5109010PACS, HCIT4369313PACS, HCIT4433887PACS, HCIT4714397CPACS, HCIT5255446PACS, HCIT4274455PACS, HCIT1693543PACS, HCIT1693543TESTPACS, HCIT4537778PACS, HCIT4392798PACS, HCIT1584981PACS, QA1102PP01, QA1114PC05, RU6265ID05, RF1647ID05, tobecreated, RU3143ID01, RU3143ID01, RU2050ID01, RF1383ID01, To be Provided , RU7579ID05, To be Provided , RF0931ID01, RU3464ID01, RU3427ID01, SA2706PP01, SA2247PP02, SA1246PP02, SA1304PP06, SA2160PP04, SA1277PP06, SA2591PP01, SA2128, SA1075PP01, SA2135, SA1025CPACS, SA2410PP01, SA1233PP06, SA1013PP17, SA2385PP01, SA2433PP02, SA1039 - CPACS, SA2315PP12, SA2581PP02, SA3053PP02_Prod, SA3053PP02_Test, SA2039PP01, SA2192, SA2329PP01, SA1005PP01 - RAD, SA1060PP08, SA1176PP01, SA1208PP01, SA2000PP01, SA1006PP07, SA2275PP02, SA2468PP01 - DF, SA2235PP01, SA1001PP28_PROD, SA1008PP01_PACS_PROD, SA1011_PACS_PROD, SA1209PP09, SA1054_PROD, SA2110PP03, SA2191PP10, SA2424PP03, SA2281PP01, SA1001PP28_TEST, SA1054_TEST, SA2645PP01, SA1008_PACS_TEST, SA1058_CPACS_WH_PROD, SA1011_PACS_TEST, SA2393PP01, SA2006PP01, SA1064PP02, SA1175-Centricity PACS EE, SA2177PP01, SA1071 - CPACS, SA2268PP01, SA2958_PACS, SA2477PP01, SA1339_CPACS7, NNI-SG-CPACS, KTPH8, ASIAMEDIC02, RADLINK10, AH-CPACS, NNI-SG-CPACS7, KTPH-SG-CPACS7, 4547195 - 6966037 - 3227712-Centricity PACS-24283964, NTFGH3, NUH-PACS, TTSH-RAD-CPACS6, TTSH-RAD-PACS-TEST, WHC-CPACS7, TTSH-RAD-CPACS7, ZA1352PP05, ZA2241PAC3, ZA2895PP02, ZA2812PAC1, ZA2412PAC21, FPG10802, FPG10902, EPP05803, FEG85600, FEG85608, FEG34405, FEG34406, FEB92518, FEB92519, FEE07A22, FEE07A23, FEG85700, FEG85704, FE410911, FE410912, DE619840, DE619846, DEM88511, DEM88512, DEM87116, DEM87121, DEI12311, DEI12312, DEP00203, 20034126, MPX06502, MPX06503, MPX23600, MPX91100, MPX43176, MPX43177, MPX43178, MPX43179, MPX43180, MPX43181, MPX91302, MPX28301, NE465120, NE670325, NE673137, NE300609, NE219643, FPD10805, FPD10806, FPD10807, FE816139, FE816140, FE8161102, DPP03300, DPP03301, DPP03302, DPP03303, DPP03305, FEG51800, FEF70522, FEF70523, YE151130, YE162A34, YP600802, GPX45803, GPX45903, MEX70164, MEX67400, MEX25523, MEX67605, MEX61704, MEX689477, MEX67314, GEX18404, GEQ20315, GEX00300, GEC21836, GE448033, GE449501, DPN08303, DEN27229, DEL26465, DEL26479, DE993820, DE993828, DE993832, DE993833, DE492A43, DE492A50, DPN08101, DPN29611, DPN29612, DPN29613, DPN29619, DPN94102, DPN96701, DPB37408, DPN69000, DPN887737, DPN95906, DPM89207, DPN87756, DPL32994, 24277780, NPV73804, NE203141, NE740521, NE216225, NE487826, DPD01000, DE539281, DE539290, DPD33502, FPD36800, NPD28000, NE723605, NEV07027, NE748614, NEV13618, NEV06838, FPD07500, NE304907, NE223245, NE419140, NEV44001, NPV84521, NPV79338, NEV44017, NEV44018, NPV79367, NPV79368, NP715206, NEV44034, NE741437, NEV35826, NE688826, UP285A29, UP285A55, GEE34022, 529010CS02, 150010PA01, 529020PC03, 437918CS01, 437918SV03, 722050CS01, 529060CS01, 475290WS05, 730140CS01, tobecreated, 0853550429, 0853550209, 0853550142, 0853550675, 0853550199, CGMHKEL20541717, 0853550804, 0853551073, 0853550616, 0853551139, 0853550223, 0853551064, CGMHTPE20541713, 0853550312, 0853550218, CGMHTAO20541704, HCIT4783733PACS, P06127PAC2, 06002PAC37, 06172PAC01, 06162PAC03, 06680PAC05, 06051PAC01, 16003PAC02, 21022PAC01, 34296PAC02, 34001PAC02, To be Provided , To be Provided , 34340PAC02, 34455PAC02, 34433PAC01.2, 34449PAC01.2, 59025PAC01.2, 34696PAC01, To be Provided , 34361PAC04.2, 34361PAC04.3, 34361PAC04.4, 34361PAC04.5, 34361PAC04.6, Temp_34118PAC01, To be Provided , 41400PAC05, 06004PAC23, AE0002PP02, AE1802PP01, AE1564PP03, AE1761PAC2, 81564SUN01, RRJ0500038, 81001VIR04, RWJ0100069, RJN7100049, 80327ISU01, 80164ISU01, DDC01VM003, RFSDAVM014, RW60200064, 85235DBS01, RVV0100002, RVVKC00067, RPA0200134, RWF0300076, RWF0300084, RVV0900052, RPA1700007, RPA2900005, RRF0100004, RM30100088, RRF0200014, RWDDAVM011, PRDC0VM045, RNQ51VM014, 80257HOS01, To be Provided , To be Provided , To be Provided , To be Provided , PRDC0VM056, PRDC0VM084, PRDC0VM100, PRDC0VM116, PRDC0VM134, PRDC0VM148, RNS01HOS01, RNS01TEST1, 85252LOA01, RX1LBTEST1, RK5BCVM002, RWFTW00008, 80674IMS01, RBK0200069, BacLieuGH-CPACS, VINMECDN07, VINMECHL07, THANHNHAN01, VINMECHAIPHONG07, VINMECPQ7, VinUni-CPACS, CHORAY01, BINHCHANHGH-CPACS, VINMECTANCANG-CPACS, VINMECNHATRANG07, NINHBINH001, VINMECINT-CPACS.
Recalling Firm/
Manufacturer		 GE Healthcare
500 W Monroe St
Chicago IL 60661-3671
For Additional Information ContactGE Healthcare Sercive
800-366-6312
Manufacturer Reason
for Recall		GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.
FDA Determined
Cause 2		Device Design
ActionGE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/05/2024 by letter delivered via traceable means. The notice explained the issue, potential risk to the patient, and requested the following: "You can continue to use your device if it has not reached the maximum number of Ckeys. In order to determine the remaining number of available Ckeys: " If GE HealthCare is remotely monitoring your Centricity PACS system as part of an existing service agreement, the number of available Ckeys is assessed routinely. If your device is close to maximum capacity, the GE HealthCare support team will contact you to discuss next steps. " If GE HealthCare is not remotely monitoring your system, please contact the GE HealthCare support team who will help you check your Ckey status. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions above." "GE HealthCare will provide an updated manual with CKey monitoring instructions at no cost to you. A GE HealthCare representative will contact you with further information." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce2138 units
DistributionWorldwide 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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