—#209804

Product

GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K043415, K110875
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

GE 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.

Recalling firm

Firm: GE Healthcare
Address: 500 W Monroe St, Chicago, Illinois 60661-3671

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-08-05
Posted by FDA: 2024-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209804. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.