CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Centricty PACS, V2, V3, V4, V6, V7 recalled by GE Healthcare
GE Healthcare is recalling Centricty PACS, V2, V3, V4, V6, V7. The recall was initiated on 5 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3214-2024
- FDA event ID
- 95243
- Recalling firm
- GE Healthcare, Chicago, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2024
- FDA classified
- 24 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 5 Aug 2024 | Recall initiated by company | |
| 24 Sep 2024 | Classified by FDA | +50 days |
| 2 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE Healthcare
All 512| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Signa Premier systems recalled by GE Healthcare | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity Universal Viewer Zero Footprint Client recalled | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled | GE Healthcare | Device Malfunction | |
| Device | CLASS II | Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare | GE Healthcare | Other | IL |
| Device | CLASS II | Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare | GE Healthcare | Other | IL |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |