GE Healthcare Centricty PACS…

Date

Oct. 2, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

GE Healthcare

Product

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

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.

Distribution pattern

Worldwide distribution.

Quantity

2138 units

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…

Recall started

Aug. 5, 2024

Device type

System, Image Processing, Radiological

Root cause (FDA)

Device Design

What the company told customers

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.

Recall number

Z-3214-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-3214-2024. The agency record governs; check it and the company before acting.