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

Recall number

Z-3214-2024

Recalling firm

GE Healthcare

Product

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

Status

Open, Classified

Initiated

2024-08-05

Posted

2024-09-24

Terminated

not on file

Reason

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

Device Design

Action

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.

Quantity

2138 units

Distribution

Worldwide distribution.

Lot, serial or model codes

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.

510(k) numbers

["K110875","K043415"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3004526608

Firm city

Chicago

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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