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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity PACS

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 Class 2 Device Recall Centricity PACSsee related information
Date Initiated by FirmJuly 31, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3168-2026
Recall Event ID 99661
510(K)NumberK043415 K110875 
Product Classification System, image processing, radiological - Product Code LLZ
ProductCentricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
Code Information UDI-DI: V4 - 00840682124430, V6 - 00840682104807, V7 - 00840682145572; System IDs: CARTI02312611 CARTI22214087T 928757VPASW 928757VPBSW 602344PVSW2 602344REPSITEB MARICOPAC02308029 602344TIMSVM 441236VPSW 805395PVSW 805395PVTSW 310349PACSSWPV UCLAMC2259090 310349PACSSWBPV UCLAMC2259063 916781CPACSSRWT PALMDALEM01810792 PALMDALEM16023955 PALMDALEM20508297 909788HCAPACS1 916781CPACSCKS 916781CPACSBCKS GSHCACPSW GSH320037250 GSHCACTPSW RANCHO02255039 RANCHOPISU2 RANCHOPTESTISU 805370HCALR VMPACS69 LOSROBLES19666790 MCANPACSW CENPACSW 303584HCAPVSW 303584REPBSW 303584HCAPVSWTESTIMS 970476PVSW VVMC15111181 VVMC27255473 302674PACSSW 302674PACSBSW 302736SAEATSW JFKSW JFKR19980220B JFKSWOPT 727462PVSW 727462PVBSW MPMH2259089T 772461HCAPACSW 772461HCAPACSW1 772461HCAPACSWT 352333PACSSW NFRH19663978B 904202BMCDSW 904202BMCSSW 904202BMCDTSW MH826898334 407518COREPACS 407518CPREPB KRMCOREPACSSW KRMC19478073 KRMC25216192 615344HCASW PCMC420084442 WFLHIV01 WESTFLORI19661467 772335PACSSW 772335PVSW 850875PVSW2 904819PVSW 904819PV2SW 904819PVTSW 727519PVBSW 850325PACSCORE CRMC820084433 888663CPBSW 727519PVSW 888663CPTSW 888663CPB2SW 727519PVTSW VAMAF02345966 727519PVTSW-MOCK 407518SCPACSHC 850325HCASWOPT WFLHIVT01 PCMC42259036 352333PACSTSW WELLINGTON01810730 WELLINGTON19678279T WELLINGTON20036598 MJPACSW TRMPACSW TRMNC20021605 100115-8-Centricity PACS-21222171 TRMTESTPACS Doctors Ho22222417 MJPACDRSW 706651HCACORE 912466PVSW SGHS2259039 912276PVSW 912276PVTSW 706278PACSSWPV 706278PACSSWBPV 706278PACSSWTPV VSMQL01987331 404325PACSSWPV 406238PVSW 641422PVSW PROSPECT2259084 PROSPECT22128566 319272SCPSWULP 319272CPDRSW 319272CPDRBSW 319272SCPTSWULP 208COREPVSW EID19660790 208CORETIMS NORTHWEST25297966T 773880PVSW 795079PACSEESW1 795079PACSEESW2 312996PVSW2 JSHPACSSW 312996PVSW1 312996PVSWT1 312996PVSWT2 795079PACST JHSJHOCC02259030 773880PVBSW 773880PVTSW JSHPACSTSW 815285PACUV100 ADVPACSTSW1 847437PVSW 847437DCPVSW 847437SAPVTSW LaitekDataMigrationCPACSLabCPACS 847990PVSW S046PACSSWPV S801PACSSWPV S046PACSSWTPV ADVPACSSW ADVPACSBSW 219325PVSW1 219325PVBSW1 219325PVTSW1 765983PVSW 765983PVSW2 RHHCS02253964T 812232PACSPV 812232PACSTPV THRH20084364 FRNKHAPACSPV FRNKHAPACSTPV FRANKFORT19633100 RRMCPACSW RGMCPACSTW RRMC120080697 VTP01810617T VHT02334235P VTP19617532 985230PVSW NOMC2259032 CFO18227240 985230PVSWS 504903CPACSSW 504903CPACSTSW 504903CPACSIMS 781979PVSW 781979PVBSW 413447BCPVSW 413447HCPVSW 413447PVSW 413748PVSW 413748PVTSW 413748PVBSW 301698PVSW 301698PVTSW NORTHE02315652 NORTHE02370307T 517353PACSEESW 517353PACSEETSW 906387VPSW 248858PVASW 248858PVBSW 248858PVTSW 507288PVSW 507288PVSWT-TESTING OMCR19625746 651855PVSW 651855PVBSW 612831PVTSW 660885PVSW 660885PVTSW S011PACSSWPV S011PACSBSW S011PACSTSW S009PACSSWPV S009PACSSWBPV S009PACSSWTPV2 GPMCCOREPACS 601288PACSSWPV DBCSW 406345SCPACSTSW 704660PVSW 704660PVTSW 402484PACSSW AMIM02031832 609652PACSSW 609652PACSBSW 609652PACSTSW VHGPVSW VHGPVBSW VHGPVTSW UMDNJPVPSW UMDNJPVPBSW UMDNJPVPTSW 505609PVSW SJRMIMST20655929 VSMAI01812924 702733CPACSSW SHPACSW SUNPACSW VALLEYHEA14460287 SUNPACSREPB 20910879CPACST NORTHERNN20284710 NORTHERNN20838223 NORTHERNN20838225 STO01440342 BLH01442255TST BLH01451970 STO02157029 STO02157030T2 718206PVSW 718206PVTSW 2435-1-Centricity PACS-20608371 718206REPBSW 315798PVSW1 315798PTISU MSKPVSW NEWYORK01976546 MSKPVBSW MSKPVTSW2 MSKPVTSW3 ERM16295285 718920PVSW 718920PVTSW1 516763PVSW 516763PVBSW 516763PVTSW1 STO18806599 914357PVSW 914357PVBSW 914357PVTSW 315470CPACSASW 315470CPACSBSW 315470CPACSTSW 914681PVSW 914681PVTSW 718920PVTSW2 330543PACSSWPV CHPA2259061 CHPA2259088T 614234PVSW 614722PVSW 614722PVBSW SAH52259083 SAH52259110T 740348PACSSW 740348PACSBSW 740348PACSTSW 419383PVSW MUOO2259017 419383PVSWB STMARYS-TISU STMARYS-PISU S040PACSSWBPV S040PACSSWAPV S040PACSSWTPV 503257PACSSWPV UHS101383446 215913CPBSW 484526PVSW1 484526PVTSW 484526CPREPB 215710PVSW SMMC14898807 QUANTUMIM14640640A QUANTUMIM14776702B QUANTUMIM14776726T 570523PVSW EVANVTPACSIMS 724728SSASW 724728SSABSW 724728SSATSW2 412575CPACSSW 412623CPBSW 215453PACSSWPV GVH102398920T 401444PVBSW 401444PVSW 401444PVTSW AIMC01810707 AIMC19632995 864716PACSSWPV 864716PACSSWT 864716PACSSWBPV 803461PACSSWPV SCOA2259023 843347PVSW 843347PVTSW CNOS02186078 TEST PQM 423493PACSW 423493REPB WTN00104692T WTN2259070 WTN2259097 423837HCASWSU 423431PVSW 865977SSASW 865977SSTSW 806354CPACS 806354CPACSB 806354CPACST7 972906GSPACSTSW 361694VPSW DRISCOLLC02257225TIMS 214820EEPVSW1 SCW2259068 FORTDUNCA01810773 FORTDUNCA20854738T FORTDUNCA21337445 DSMCCOREPACSSW DSMCCOREPACSDRSW DSMC-22886533 972906GSPACSSW HCA-NORT02332691 MEDIC01812756 281274MSLPVSW 713441MHPVSWA 713704MHMSWA 713704MHMSWB 713704MHMSWTA 713704MHMSWTB 713741MHHPVSWB 832522MWHPVSW DHOL01810756 DHOL15291375T DHOL20631410 DHOL23253841 214820EEPVSW2 254724PVSW SCW2259095 361572SSASW CMDC2259015 801DASSW 801DSWSP1 801SOFTWARE 801SOFTWAREOPT SMH820071869 SMH8-26535851 SMH8-26535857 LGMSW LGHI20084372 STSP21736781 802775SSASW 802775SSATSW4X 206292PACSSWPV 206545EESW UWH20021873REPB 414465PVSW 414465PVTASW 414465PVTBSW 414465PVBSW 304487PVSW PCH12259035-TISU DZ1906PP02 DZ27??PP03 DZ2112CC01 HCIT1555339PACS HCIT4825134PACS HCIT4691855PACS HCIT5184728CPACS HCIT4859945PACS 0910553037 0910553037 ANZVICCAUL ANZVICSAND AH0104CS01 AH5045CS01 BH1038PC01 22303605 010120ST03 010120ST52 300013ST11 HCIT4691866CPACS HCIT4691855CPACS HCIT4759526PACS 4863935_CPACS HCIT7102800PACS HCIT4852374PACS-IMS HCIT5245250CPACS HCIT4860936PACS HCIT5317135CPACS HCIT4290686PACS HCIT5245275CPACS HCIT5471924PACS HCIT7104315PACS HCIT5245248CPACS HCIT5245248TESTCPACS HCIT7229698PACS 604520REPSITEA 604520TESTIMS 604586REPSITEB 709737PACS 709752IMSAsw 709752IMSBsw 709752GEPACS 709752DCSDAS02sw 709752DCSDAS04sw 709752TESTIMSsw 709752REPSERVERsw 709752DCSDAS01sw 709752DCSDAS03sw 709752DASNLA01 709752DASNLA02 709752DASNLA03 709752DASNLA04 709752DASNLA05 709752DASNLA06 709752DASNLB01 709752DASNLB02 709752DASNLB04 709752DASNLB05 709752DASNLB06 709752DASNLB07 709752DASNLB08 709752DASNLB09 709752DASNLB10 709752DASNLB12 709752DASNLB13 709752DASNLB14 709752DASNLB15 709737UTILITYsw 709752ITS2sw 709752ITS1sw 709752CORDMODsw 709651DASGA03 709292PACS 519426IMS 519426TESTIMS 519426GEPACS 709454PACS 905522GEPACS 905521GEPACS 905521IMSA 905522IMSB 905521TESTIMS 905575IMS 613732GEPACS 613732IMS 613732TESTIMS 416813REPSITEB 416813REPSITEA 416813TESTIMS 416813GEPACS 416326IMS1 416326IMS2 416326GEPACS 905372GEPACS 905372IMSA 905372IMSB 905372TESTIMS HCIT4602438PACS HCIT4920063PACS HCIT4096494PACS HCIT4601968PACS HCIT5026141PACS HCIT5183890CPACS 082499310155 082455150052 082455150052 082455160221 082455160221 082499180109 082499180102 082499180106 082455160255 082427190180 082445110005 082455190146 082499130790 082499130125 082499130790 082499020074 082499100188 082455040339 082407040684 082407040684 82455040334 082455040339 082455040147 082455040352 082445040028 082455040317 SiteID-Centricity PACS-20608297 082407040684 082499110183 82499220115 082499100382 082455150074 082455150068 082455180040 082499180080 082499010124 082499060054 082499100386 082499100386 na 082499100461 082455100286 082499250135 082455070037 082455120548 082455120548 082455100352 082455100179 082455100179 082455160241 082433120225 082499120374 082455120507 082499250135 082455120545 082455120552 082455120510 082499100188 082455130065 082455130335 82455290014 082499130780 082455130366 082455130394 082455290015 082499180085 082445030013 082455160035 082499130792 082455120226 082455080025 082455060004 082455050079 082455050076 082455050069 tbd 082455130415 082427150109 082455120544 13767625-Centricity PACS-21273767 082499130816 082499130826 082455080026 082407120583 082455100357 082499100415 082499230063 SH EASTERN HEP24523158 HCIT50000107PACS HCIT4946501PACS DoNotUse-DK9154CA01 DK9066IMS1 DK9066TESTPAC1 DK9066IMS2 DK9066TESTPAC2 HCIT4277575PACS HCIT4692615PACS HCIT4796839PACS EG1526PP02 EG1017PP02 HCIT5162696CPACS ZA2879PP01 M4477025 A4167665 22106615 A4498636 HCL_24968096 M61421909 M100323902 M2030921 M2753440 M4171826 M4476437 X59655539 Not Available M4206540 M5172536 M5172537 M5172568 P4172826 P4172827 MQ1234502 M386578303 A27411 M4144112 M4045536 M4046544 M4047061 M40480163 M4188439 M54807112 NC1028 M4491536 PF1000PC02 M143153109 M4143924 M4143984 M220995201 02398902 M4825009 / M4825010 / M4825011 M4204530 H4858984 D4858905 D4858906 D4858918 M838835602 M4209925 M4209926 M4209927 Utuora HNO M4505229 HC2641CS01 Not Available 744459PA02 HC0220CS01 518086CS01 HC2720CS02 HC4017CS01 UC2847CS01 UESS01CS01 126292CS01 UJJF01CS01 416005CS01 HC4912CS01 530366PC03 HC0468CS02 556162CS01 UHAM02CS02 HC0727CS01 tobecreated UHAN01CS01 UHAN01CS01P HHEI01CS01 HC7048CS02 410014SV02 HC1992CS01 HC2554CS01 tobecreated 624751CS01 HC0014CS01 Not Available HC1467PA01 560496CS01 145774CS01 HCNE01CS01 HC0094CS01 553160CS01 434487CS01 HCSC01CS01 UC4372SV02 HC0863CS01 Not Available HC1282CS01 424881PA01 0828550074 0828550085 0828550070 828550079 0828550105 0828550072 0828550068 0828550068 0828550068 828550052IB01 828550064 828550066 828550052IB01 828550095 0828550073 0828550111 0828550071 0828550071 0828550071 0828550086 0828550086 828550057 083055283270418 MAX-DC-PACS 083055003435816 083055247345516 083055820666618 MCC-CPACS SCTIMST-IN-CPACS RCC - CPCS 7.0.0.4.8 083055201766451 SIRHNHOSPITALTRUST-CPACS Wockhardt-CPACS7.0.0.4.8 INHS-ASWINI-CPACS 083055211206517 ACTREC26874950 AIIMS-NM-PACS JIPMER-CPACS Not Available 083055803467916 083055801005510 SRK-CPACS 083055808240917 NARUVI -CPACS 083055840003710 CARE-DC-CPACS CHL-CPACS TMCV_CPACS 083055604732915_CPACS RSMITRAKELUARGABINTARO-CPACS RSUDBERKAHP-CPACS RSMKG-SERPONG01 BETHSAIDA-CPACS RSUDMukomuko-CPACS RSUDSOREANG-CPACS RSUDMadaniPalu-CPACS RSMKKEMAYORAN-CPACS RSUDKOTAJOGJA-CPACS MayapadaBandung-CPACS TEASIAHEALTHCARE-CPACS RSHARAPANKITA-CPACS RSKELUARGAKALIDERES-CPACS RSUDTarakan-CPACS PTMKMas02 PTSentosa1 RSUPFATMAWATI-CPACS RSPOLRIB-CPACS RSMK-KelapaGading01 SULIANTI001 PTUROGEN01 SiteID-Centricity PACS-20535377 RSUPTVertikalKupang-CPACS RSUDHMB-CPACS SANTOSA-CPACS HASANSADIKIN-EA RSMK-Cibubur01 RSUDBEKASI-CPACS MKCikarang-CPACS MKBekasiBarat-CPACS MKBEKASITIMUR_CPACS RSUDCIAWI-CPACS RSMITRAKD-CPACS SYAMSUDIN001 RSUDPandanArang-CPACS RSUDDRMAP-CPACS RSUDKRMTW-CPACS RSJDSurakarta-CPACS RSUDSlawi-CPACS RSDDRSJ-CPACS RSUDPasirian-CPACS RSUDSidoarjo-CPACS RSMITRAKW-CPACS RSALDr.Ramelan-CPACS RSHajiSurabaya-CPACS RSPHCSurabaya-CPACS RSUDTuban-CPACS RSUDKabupatenB-CPACS RSUDTarakanKaltara-CPACS RSUDLeimena-CPACS RSReginaMaris-CPACS RSUDKlungkung-CPACS RSPBINTARO2 MITRAKELUARGATEGAL-CPACS RSUDDRHKB-CPACS PTUNISIAMEDIKAFARMA_CPACS RSPJATINNEGARA1 MitraKeluargaSlawi-CPACS RSMardiRahayu-CPACS RSUDBHAKTIDHARMAHUSADA-CPACS RSUPSOERADJI-CPACS Dr.MOHAMMADZYN_CPACS MitraKeluargaDeltamas-CPACS RSMKSS-CPACS RSMITRAKK-CPACS RSUPDr.Wahidin-CPACS RSUDPadangan-CPACS RSPSURABAYA1 PTSEJANU01 MitraKeluargaPamulang-CPACS RSMITRA-CPACS RSUDProvinsiNTB-CPACS RSUDKOTADUMAI-CPACS RSUDKKM-CPACS RSUDTelukKuantan-CPACS RSOtak-CPACS RSUPM.DJAMIL-CPACS RSUDPalembang_CPACS HoesinPALEMBANG-CPACS RSUDSIJUNJUNG-CPACS MitraKeluargaJatiasih-CPACS RSBinaHusadaCibinong-CPACS RSUDPANDEGA-CPACS IQ1906PC03 IQ1727PC03 81100DAS05 IL1018IT01 IL1059IT01 Not Available IL1484IT01 IL1469IT08 IL1098IT10 01423795 01452223 A51043144 A5802803 C5368613 A5368605 A5801809 B5368603 A5630621 01452224 01979741 A5353013 01452218 A5660044 A6085807 01452220 C5603910 A5105147 A670060230 A5156018 A5119431 A5719805 26648960 B5105141 JL1748 YP5025-Centricity PACS-02170316 JA0842 JDS021 JL1715 JAS007 JDS028 JDS029 JDS030 JL1726 JAS023 JDS084 JDS085 JDS139 JL1744 JL1717 JAS009 JDS035 JDS036 JDS037 JDS043 JL1754 JA0832 JD1164 JD1165 JD1166 YP4012-080218-Centricity PACS-20579603 JL1743 JAS041 JL1751 JD1275 YP5018-Centricity PACS-02013203 JL1755 JAS039 JL1739 JAS035 JAS022 JDS082 JDS083 YP5040-Centricity PACS-19737087 JL1741 JAS036 JL1393 JD1015 JD1016 JDS133 YP5047-Centricity PACS-20617590 YP5044-Centricity PACS-20484083 JAS027 YP5028-Centricity PACS-02248290 JDS003 YP5013-Centricity PACS-18045997 JL1725 JAS021 JDS077 JDS078 JDS079 JDS080 JDS081 JL1702 JD1250 JD1252 JD1254 JD1253 JD1255 JA0895 JD1251 JDS022 JDS023 JDS024 JDS025 JL1729 JAS025 JDS094 JDS095 JDS096 JDS097 JAS026 JDS099 JDS100 YP5041-Centricity PACS-20084062 JA0899 JD1268 JD1269 JD1270 JL1705 JD1267 YP5017-160102-Centricity PACS-20574044 JA0898 YP5031-Centricity PACS-02332510 JDS042 JL1745 JAS037 JL1728 JAS024 JDS087 JDS088 JDS089 JDS090 JDS091 JDS092 JDS093 YP5037-Centricity PACS-15349241 JDS058 JDS059 JDS004 YP5015-221077-Centricity PACS-20574038 JL1704 JDS014 JDS015 JDS016 JDS012 JDS013 JAS003 JDS031 YP5021-240130-Centricity PACS-20574046 JDS223 YP5026-Centricity PACS-02253241 JDS017 JDS018 JAS005 YP5033-Centricity PACS-02399305 JAS011 JDS044 JDS045 JDS046 JL1746 JL1733 JAS030 JDS125 JDS126 JDS127 JDS128 JDS129 JDS130 JDS131 JDS132 JL1749 JAS038 YP5050-Centricity PACS-21180376 JDS105 JL1731 JDS103 JDS104 JAS028 JDS114 JDS115 JDS116 YP5022-Centricity PACS-02285739 JDS033 JDS034 JL1736 YP5049-Centricity PACS-20978976 JL1752 JL1417 JA0835 JD1187 JD1188 JD1189 JD1190 YP5034-Centricity PACS-14194563 JDS047 YP5038-Centricity PACS-16450968 JDS112 JDS113 YP5045-Centricity PACS-20509113 JL1735 JAS032 JDS140 JDS141 JDS142 JDS143 JDS144 JDS145 JL1146 JD0774 JD0775 JD1128 JD1125 JD1126 JD1127 JD0961 JA0278 JL1710 JD1261 JD1262 JD1263 JA0901 JL1712 JA0900 JD1271 JD1272 JD1273 JL1747 JDS101 JDS102 YP5042-Centricity PACS-20101281 YP5030-Centricity PACS-02274229 JDS032 JL1750 JL1721 JDS062 JDS063 JDS064 JAS017 JL1720 JAS013 JDS052 JDS053 JDS054 JDS055 YP5035-Centricity PACS-15111123 YP4011-Centricity PACS-20584824 JL1732 JDS123 JAS029 JDS117 JDS118 JDS119 JDS120 JDS121 JDS122 YP5009-532345-Centricity PACS-20574025 JL1719 JAS012 JDS048 JDS049 JDS050 JDS051 JL1738 JD1148 JD1138 JD1140 JD1146 JD1147 JD1139 JA0831 JL1740 YP5048-Centricity PACS-20644650 JDS146 JL1756 JL1753 YP5039-Centricity PACS-19629898 JAS016 JDS061 YP5023-Centricity PACS-02256894 JAS006 JDS026 JDS027 JL1724 JAS020 JDS073 JDS074 JDS075 JDS076 JL1390 JD0991 JA0301 JL1734 JDS134 JDS135 JDS136 JDS137 JAS031 JDS138 JD0962 YP5019-Centricity PACS-02042638 YP5036-Centricity PACS-15261448 JDS056 JDS057 JL1742 JL1723 JAS019 JDS069 JDS070 JDS071 JDS072 JL1722 JAS018 JDS065 JDS066 JDS067 JDS068 KE2701CP01 KE0802CP01 KE0402CP01 KE1402PAC01 KE1110CP01 KE2001CP01 KE2202CP01 KE0301CP01 KE0202CP01 KE4705CP01 KE1502CP01 KE0201CP01 KE1602CP01 KE1701CP01 KE0302CP01 KE1111CP01 KE1201CP01 KE4701CP01 KE3004CP01 KE4704CP01 KE4601CP01 KE4101CP01 KE2201CP01 KE3402CP01 KE0601CP01 KE0702CP01 0850550196 0850550306 0850550243 0850550300 0850550115 0850550322 0850550321 0850550139 0850550238 852004_RAD-Centricity PACS-20542654 KW1147WS01 KW1155PC09 KW1155PC02 KW1102PC02 KW1163PC06 KW1012PC01 KW1011PC04 KW1003-CPACSv7 Not Available KW1007PP02 KW1004PC02 KW1019SAHP KW1013PC04 KW1001PC06 KW1005PC01 KW1096PC01 KW1190PC03 KW1093PC03 LB1160SV01 LB1462PC01 LB1000PC01 LB1485PC01 LB1001PC04 LB1497PC04 HUSM008 UMMC-CPACS7 PSH-CPACS7 MMC2 HSB-CPACS UNIMAS-CPACS REGENCY-CPACS IPPT4 PKHS-CPACS Lifecare-CPACS Hospital Sultan Abdul Halim, Sungai Petani_PACS IIUM-CPACS UTAR-CPACS AMPANG6 LIFECARE6 SGB-CPACS HPU-CPACS HCIT4579183PACS HCIT4665855PACS HCIT4825663CPACS HCIT4784198PACS HCIT4753028CPACS HCIT4820102PACS-SPS HCIT4865124PACS-IMS HCIT4753028CPACS AMS3960 OM1181PC01 OM1109PC01 HCIT5109010PACS HCIT4369313PACS HCIT4714397CPACS HCIT4274455PACS HCIT1693543PACS HCIT4537778PACS QA1102PP01 QA1114PC05 SA2706PP01 SA1232PP06 SA2128 SA2192_CPACS SA1060PP08 SA2410PP01 SA1233PP06 SA1246PP02 SA1304PP06 SA2385PP01 SA2160PP04 SA2433PP02 SA1039 - CPACS SA2581PP02 SA3053PP02_Prod SA3053PP02_Test SA2329PP01 SA1005PP01 - RAD SA1176PP01 SA2275PP02 SA1025CPACS SA1001PP28_PROD SA1008PP01_PACS_PROD SA1011_PACS_PROD SA1209PP09 SA1054_Central_CPACS_PROD SA2247PP02 SA2110PP03 SA2191PP10 SA2424PP03 SA1001PP28_TEST SA1071 - CPACS SA1054_Central_CPACS_TEST SA2645PP01 SA1008_PACS_TEST SA2958_PACS SA1058_CPACS_WH_PROD SA1011_PACS_TEST SA1339_CPACS7 SA2393PP01 SA2006PP01 SA1175-Centricity PACS EE SA1234_PACS SA1277PP06 RADLINK10 NNI-SG-CPACS7 SG-KTPH-CPACS7 930879-Centricity PACS-24821325 AH-CPACS7 TTSH-RAD-CPACS7-TEST WHC-CPACS7-PROD TTSH-RAD-CPACS7 NUH-SG-CPACS7 WHC-CPACS7-TEST ZA1352PP05 ZA2241PAC3 ZA2812PAC1 ZA2412PAC21 FPG10802 FPG10902 EPP05803 MPX06502 MPX06503 MPX23600 MPX91100 MPX43176 MPX43177 MPX43178 MPX43179 MPX43180 MPX43181 MPX91302 MPX28301 YE151130 YE162A34 YP600802 MCORUNADAS MEX70164 MEX67400 MEX25523 MEX689477 GEC21836 DPN08303 DEN27229 DEL26465 DEL26479 DPN94102 DE993820 DE993828 DE993832 DE993833 DE492A43 DE492A50 DPN08101 DPN29611 DPN29612 DPN29613 DPN29619 DPN96701 DPB37408 DPN69000 DPN887737 DPN95906 DPM89207 DPN87756 DPL32994 24277780 DPN29631 24864745 24855932 GEQ20315 26354119 FPD10805 FPD10806 FPD10807 DPD01000 DE539281 DE539290 DPD33502 24498903 25311027 FPD36800 NPD28000 MPALMADAS MSABDAS1 FPD07500 GE448033 GE449501 NPV79338 NPV79367 NPV79368 NP715206 Not Available UP285A29 UP285A55 150010PA01 529020PC03 730140CS01 0853550429 0853550209 0853550142 0853550675 0853550199 CGMHKEL20541717 0853550804 0853551073 0853550616 0853551139 0853551064 CGMHTPE20541713 6935589 0853550312 0853550218 CGMHTAO20541704 HCIT4783733PACS 06162PAC03 06680PAC05 Not Available 34340PAC02 34455PAC02 34433PAC01.2 59025PAC01.2 34696PAC01 34361PAC04.2 34361PAC04.3 34361PAC04.4 34361PAC04.5 34361PAC04.6 Temp_34118PAC01 Not Available 41400PAC05 06004PAC23 AE0002PP02 AE1802PP01 AE1564PP03 RRJ0500038 80327ISU01 80164ISU01 DDC01VM003 RFSDAVM014 RWDDAVM011 PRDC0VM217 RNQ51VM014 80257HOS01 TBD 21367995 TBC 00163553 Not Available TBC PRDC0VM056 PRDC0VM084 PRDC0VM100 PRDC0VM116 PRDC0VM134 PRDC0VM148 PRDC0VM218 PRDC0VM219 PRDC0VM220 TBC RNS01HOS01 RNS01TEST1 RX1LBTEST1 RK5BCVM002 80674IMS01 TBC RBK0200069 RBK25276764T BacLieuGH-CPACS BacLieuGH-NB-CPACS VINMECDN07 VINMECHAIPHONG07 VINMECINT-CPACS VINMECTANCANG-CPACS 16880525-Centricity PACS-2723310 VINMECNHATRANG07 VINMECPQ7 NINHBINH001 THANHNHAN01 NCH-Phase2-CPACS VinUni-CPACS VINMECHL07
FEI Number 3004526608
Recalling Firm/
Manufacturer		 GE Healthcare
500 W Monroe St
Chicago IL 60661-3671
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your systems by following the instructions below. 1. Do not perform any new inbound data (DICOM) migration projects. Please contact GE HealthCare before starting any new migration projects. 2. If using Enterprise Archive with Core Services Hub/Workflow Core Services, when reviewing or exporting prior imaging studies after migration to Enterprise Archive, verify that the study and images within the study are associated with the correct patient as follows: At the Study level: " Compare name, date of birth, and patient identifiers only if burned-in or embedded in the image. Do not rely on patient information in the image overlays that can be toggled on and off. " If burned-in or embedded patient identifiers are not available, compare with prior studies based on patient anatomy, implants, or unique anatomical features. At the Image level: " Confirm that the images within the study do not belong to different patients based on acquisition date and time or other patient identifiers. Please maintain any previous source systems or migration servers pending correction of this issue by GE HealthCare. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions above. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 85492 Digital Response Form or print, fill out manually, scan, and email to recall.85492@gehealthcare.com. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce1443 systems
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
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