510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-3214-2024Class II

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

GE Healthcare / initiated 2024-08-05 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

GE Healthcare began a recall of GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-3214-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
GE Healthcare
Product
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Product code
LLZ System, Image Processing, Radiological
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.
Root cause tag
design
FDA 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 in commerce
2138 units
Distribution
Worldwide distribution.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-3214-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-3214-2024Class IIOngoingVoluntary: Firm initiated