{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "222118", "product_res_number": "Z-3166-2026", "event_date_initiated": "2026-07-31", "event_date_posted": "2026-09-15", "recall_status": "Open, Classified", "res_event_number": "99661", "product_code": "LLZ", "k_numbers": [ "K043415", "K110875" ], "product_description": "Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions", "code_info": "UDI-DI: V4 - 00840682102766;\nSystem IDs: 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Archive-24509241\nHCIT4859945EA\n83191934072\n0910558008\n0910558008\n834IT000002\n0910553037\n0910553037\n83177663003\nAH4325PC02\nAP9147PC01\nAH5291PC03\nAH0104PC01\nAP6264PC02\n01452306\nAH0106PC01\nHSSTEA01\nHSSTEA02\n030157ST02\n030157ST04\n040164ST01\n040164ST04\n040164ST04\n300013ST01\nHCIT4691866EALTS\nHCIT4691855EA\nHCIT4759526EALTS\nza00122\nHCIT7102800EA\nHCIT4852374EA\nHCIT4860936EA\nHCIT4290686EA\nHCIT1725478EALTS1\nHCIT4990321EAGW\nHCIT7103264EA\nHCIT7104315EA\nHCIT5245248EALTS\nHCIT5245248EAGTWPO\nHCIT5245248EAGTWIP\nHCIT5245248EATEST\nHCIT5245248EAGT-ST\nHCIT1424246EA\nHCIT1424246EA\n604875EAKDC\n604875TESTEA\n604520AIM40\n604520EA40ISITE\n604520TESTEA\n250565AWEACACHE\n604586EA\n604586EA40MAMMO\n604586FHAWEACACHE\n604586AIM40\n604586ECHOEA\n604875EAMAIN\n709752NLEA1\n709752EAGATEWAY\n709752NLEA2\n709752TESTEA\n519426AIM\n519426TESTAIM\n905521CWEA1\n905521HHSTESTAIM\n905521HHSAIM\n905522SJHHAIM\n905522SJHHTESTAIM\n905521TESTCWEA1\n613548EAHDIRS\n613548TESTAIMRET\n613548TESTEA\n613548AIMRET\n613548EALEGACY\n905575EA\n905895DIEA\n905895TESTEA\n613732AIM\n613732XEDEA\n613732TESTAIM\n705523EAAPPB11\n705523EADBB\n705523EA-B\n705523EAAPPB1\n705523EAAPPB2\n705523EAAPPB3\n705523EAAPPB4\n705523EAAPPB5\n705523EAAPPB6\n705523EAAPPB7\n705523EAAPPB8\n705523EAAPPB9\n705523EAAPPB10\n416326EA\n416813DREA40\n416813AIMARC\n416813AIMRET\n416813EA40\n416813DRAIMARC\n416813DRAIMRET\n416813TESTAIMARC\n416813TESTAIMRET\n416461EA\n905372TESTAIM\n905372EA\n905372AIM\n705675EAAPPA10\n705675EAAPPA11\n705675QAEAAPP1\n705675EADBA1\n705675EADBA2\n705675EAAPPA9\n705675QAEAAPP2\n705675EAAPPA1\n705675EAAPPA2\n705675EAAPPA3\n705675EAAPPA4\n705675EAAPPA5\n705675EAAPPA6\n705675EAAPPA7\n705675EAAPPA8\n705675QAEADB\n705675TESTEA\n705675QAEA\nHCIT4567313EA\nHCIT5026141EA\nNot Available\n082455160221\n082455160237\n082499180102\n082499190198\n082445110005\n082455060001\ntbd\n082499130790\n082499130124\n082499020074\n082499030205\nSiteID-Centricity Enterprise Archive-20608302\nSiteID-Centricity Enterprise Archive-20608323\nSiteID-Centricity Enterprise Archive-20608324\nSiteID-Centricity Enterprise Archive-20608390\nSiteID-Centricity Enterprise Archive-20608393\nSiteID-Centricity Enterprise Archive-20608394\nSiteID-Centricity Enterprise Archive-20608408\nSiteID-Centricity Enterprise Archive-20608410\n082455040342\nSiteID-Centricity Enterprise Archive-20637766\n082455040321\n082499290047\n082499290047\n082455040025\n1359772-Centricity Enterprise Archive-21327383\n082421230658\n082499220115\n82455230016\n082455030073\n82455150068\n82455150074\nSiteID-Centricity Enterprise Archive-20608838\n082455180040\n082499180080\n082499060054\n082499100395\nSiteID-Centricity Enterprise Archive-20594649\nSiteID-Centricity Enterprise Archive-20594650\nSiteID-Centricity Enterprise Archive-20606492\nSiteID-Centricity Enterprise Archive-20595019\nSiteID-Centricity Enterprise Archive-20541554\n647002-Centricity Enterprise Archive-22252504\n82499100387\n082499100394\nSiteID-Centricity Enterprise Archive-20606493\n082433120225\n082455180042\n082455180041\nSiteID-Centricity Enterprise Archive-20594360\n082455120545\n082499100188\n82455290014\n082421130135\nSiteID-Centricity Enterprise Archive-20611137\nSiteID-Centricity Enterprise Archive-20611755\nSH-CH-Centricity Enterprise Archive-20614728\n82455130335\n82455130055\n82455130394\n82455130224\n082499180085\n082455160035\n82455120514\nSiteID-Centricity Enterprise Archive-20594353\n82455120227\nJS KUNSHAN 123253814\n82455080025\nSiteID-Centricity Enterprise Archive-20608412\n082421050162\nSiteID-Centricity Enterprise Archive-20608172\n417238-Centricity Enterprise Archive-21273761\n082455050069\ntbd\n082427150109\n082455130415\n082499310137\n082499130813\n082499130813\n082499130813\n082499130813\n082499130813\n082499130813\n082499130811\n13767625-Centricity Enterprise Archive-21273766\n082455080027\n82455120448\n82455120448\n082499100401\nSiteID-Centricity Enterprise Archive-20594911\nSiteID-Centricity Enterprise Archive-20606528\nSiteID-Centricity Enterprise Archive-20611846\n082499310166\nSH EASTERN HEP24523160\n082499310161\n082499230207\n082499230207\n082455140069\n082455140085\nHCIT1630952EA-APP\nHCIT4946501EA\nHCIT4277575EA1\nHCIT4692615EA\nHCIT4796839EA\nEG1017PP01\nNot Available\nGE2000\nHansa1234\nZA2879PP03\nTo be defined\nM4477016\nA4167672\nE4167639\nA4498647\nNA\n89980420081077\nM61421914\nM100323906\nM100323908\nA4171560\nM4171829\nM2753416\nM4476431\nX59655541\nNot Available\nM4206536\nM5172580\nM5172550\nP4172842\nM23084326\nB1965419\nB1965420\nMQ1234509\nMQ1234504\n20031339\nM4485024\nM4485024\nM4482630\nNC1075PC01\nM386578308\nM117165201\n20031333\nA2741114\nA2741111\nA5485260\nA5485261\nM4144129\nDC GHT13 - Test - EA4\nDC GHT13 - Prod - EA4 Server 1\nDC GHT13 - Prod - EA4 Server 2\nDC GHT13 - Prod - EA_C360\nM4188439\nI9237517\nM5480763\nAHP24908218P\nNC1028WS01\nNC1028PC01\nM4712027\nA9190158\nA9190159\nM4491543\nPF1000PC05\nM7417701\nM4143983\nM220995204\n02398906\nM117565101\nM4825003\nM4204530\nM4484531\nM838835606\nD4858908\nM4209922\nM348856923\nM348856925\nM4487540\nM348856912\nM348856913\nM348856919_EDLC_EA_DataCenter\nM143153111\nUtuora\nM4217627\nM4505283\nM4505294\nA2943407\nM454662403\nHC0399PC02\ntobecreated\nPC1695PC02\n511349PC01\n609334PC01\nHC4348PC02\nHC1451SV03\nHC2636PC02\n744459PC02\n511685PC01\nHBON01PC01\n387042PC02\n518086PC01\nPC3003PC01\nHC1249PC01\n02093419\nHC0074PC02\nPC0114PC02\nHC3643PC01\nHC1666PC02\n387194PC01\nHC9502PC01\nUESS01PC02\n126292PC02\nUJJF01PC07\nn/a\n530366PC01\n416005PC01\nHC4014PC01\nNA\nHC0468PC01\n600791PC01\n556162PC01\nHC0727PC01\n362520PC02\nHHAN01PC02\nUHAN01PC03\nHHEI01PC02\n374565PC01\nevkhcr-26921624\n410014PC01\nHC1992PC03\nHC5284PC05\nHC2554PC03\n490661PC01\nHL0090PC02\n624751SV03\nCC0668PC02\nNA\nHC0014PC02\nHX1642PC01\n145774PC01\nHCNE01PC01\nHC1819PC07\nHC0094PC01\n553160PC01\n434487PC01\nn/a\nHC0536IS02\nNot Available\nUC4372PC03\nUC4372DMEA01\n509585PC01\nHC0565PC02\nHC0863PC02\nHC1282PC01\n424881PC02\nTBD\nNA\nTBD\nH1892IIS14\nH1787IIS21\nTBC\nTBD\nH44432AW24\nTBD\n828550053\n0828550074\n0828550114\n828550079\n0828550070\n0828550072\n0828550083\n0828550068\n0828550068\n0828550074\n828550064\n828550052IB01\n828550064\n828550020\n828450021AWSEA\n828550056EA1\n828550058\n0828550020\n0828550089\n0828550091\n828551005EA1\nSiteID-Centricity Enterprise Archive 4.0-20608845\n828550095\nN.A.\n0828550082\n0828550071\n0828550071\n0828550067\n0828550109\n828550057\nHU1697SW01\nTBD\nNot Available\nTBD_SAN_EA\nAIIMS-MANGALAGIRI-EA\nSIDDHARTHA_EA\nCARE-VIZAG2-EA-ROUTER\nPGI-EA-001\n083055283270418\nEA-HLL-AIIMS-RAIPUR-1\nCARE-RAIPUR-EA\n083055003435816\n083055003435816\nMAX-DC-EA\nMAX-DC-EA-LTA\nAIIMS-EA-0001\n083055247345716\nEA-AIIMS-NCI-JHAJJAR-01\nNot Available\n083055820666518\nMCC-EA\nSCTIMST-IN-EA\nRCC_EA\nSIRHNHOSPITALTRUST-EA\n083055201766451\nWockhardt-EA\n083055211206517\nCARE-NAGPUR-EA-ROUTER\nAIIMS-NAGPUR-EA\n083055209510118\nACTREC26874956\nCARE-UC-EA-ROUTER\nCARE-MC-EA-ROUTER\nCARE-RC-EA\nCARE-CN-EA-ROUTER\nCARE-CH-EA-ROUTER\nCARE-GCN-EA-ROUTER\nCARE-VZH-EA-ROUTER\nCARE-CM-EA-ROUTER\nCARE-QCOP-EA-ROUTER\nCARE-CHB-EA\nAIIMS-NM-EA\nKMCH-SULUR-EA\nCARE-VIZAG-EA-ROUTER\nSIKSHA-EA\nCARE-BBSR-EA\nJIPMER-EA-LTA\nJIPMER-EA-SHADOW\nJIPMER-EA-ROUT\nPBM-EA-001\n083055803467916\nKMCH-MAIN-EALTA\nSRK-EALTA\nKMCH-KP-EA\nKMCH-MAIN-EA-ROUT\nNARUVI-EA\nCMC-Centricity EA-01\nCARE-DC-EALTA\n083055840003710_EA\nNIZAM-EA\nMNJ-EA\nCARE-OP-EA-ROUTER\nCARE-MC-EA-ROUTER\nCARE-MUSHEERABAD-EA-ROUTER\n263394-Centricity Enterprise Archive-27109645\nCARE-NAMPALY-EA-ROUTER\nCHL-EA\nCARE-HITEC-EA-ROUTER\n083055604732915_EA\nSouthEastRAILWAY-EA\nHSCC_CNCI_KOLKATA_EA\nRSMITRAKELUARGABINTARO-EA\nRSUDBERKAHP-EA\nRSMKG-SERPONG03\nBETHSAIDA-EA\nRSUDMukomuko-EA\nINDRIATI001\nRSMKKEMAYORAN-EA\nRSUDKOTAJOGJA-EA\nRSHARAPANKITA-EA\nRSUDTarakan-EA\nPTMKMas05\nPTSentosa3\nRSUPFATMAWATI-EA\nRSPOLRIB-EA\nSULIANTI002\nRSMK-KelapaGading04\nPTUROGEN05\nSiteID-Centricity Enterprise Archive-20535379\nRSUDHMB-EA\nHASANSADIKIN-EA\nRSMK-Cibubur04\nMKCikarang-EA\nMKBekasiBarat-EA\nMKBEKASITIMUR_EA\nRSUDBEKASI-EA\nRSUDCIAWI-EA\nRSMITRAKD-EA\nSYAMSUDIN005\nRSUDPandanArang-EA\nRSUDDRMAP-EA\nRSUDKRMTW-EA\nRSJDSurakarta-EA\nRSDDRSJ-EA\nRSUDPasirian-EA\nRSUDSidoarjo-EA\nRSMITRAKW-EA\nRSALDr.Ramelan-EA\nRSHajiSurabaya-EA\nRSPHCSurabaya-EA\nRSUDTuban-EA\nRSUDKabupatenB-EA\nRSUDTarakanKaltara-EA\nUripSumoharjo1\nRSUDLeimena-EA\nRSBINTARO05\nMITRAKELUARGATEGAL-EA\nRSUDDRHKB-EA\nRSUDBHAKTIDHARMAHUSADA-EA\nRSUPSOERADJI-EA\nMitraKeluargaDeltamas-EA\nRSMKSS-EA\nRSMITRAKK-EA\nRSUPDr.Wahidin-EA\nRSUDPadangan-EA\nRSPSURABAYA6\nPTSEJANU04\nRSMITRA-EA\nRSUDProvinsiNTB-EA\nRSUDKOTADUMAI-EA\nRSUDKKM-EA\nRSOtak-EA\nRSUPM.DJAMIL-EA\nRSUDPalembang_EA\nRSUDSIJUNJUNG-EA\nMitraKeluargaJatiasih-EA\nRSUDPANDEGA-EA\nNot Available\n81100EA001\ntbc1\n23674859\nIL1469IT02\nIL1098IT17\nB5167325\nA51043279\nTBC\nB5368607\nB5365906\nA5123518\nNot Available\nA5630614\nA212223401\nMAR-EA-PROD01\nMAR-EA-PROD02\nMAR-EA-PROD03\nMAR-EA-TEST\nA5210805\n20632714\nNot Available\n01454806\nTBD\nA6085806\nTBD\nA5103534\n24429866\nA5105199\nA5188549\nA670060228\nA5156031\n25152588\nA5721909\nA378444702\n01762793\nYP5025-Centricity Enterprise Archive-02166386\nPV2009\nPV2035\nPV2016\nPV2027\nPV2041\nPV1227\nYP5018-Centricity Enterprise Archive-02040816\nYP5040-Centricity Enterprise Archive-19983945\nPV0846\nPV2061\nPV1065\nPV1049\nPV5011\nYP5047-Centricity Enterprise Archive-20617591\nYP5044-Centricity Enterprise Archive-20484084\nYP5028-Centricity Enterprise Archive-02248294\nYP5013-Centricity Enterprise Archive-18045998\nPV0893\nPV2034\nPV2020\nPV2021\nPV0832\nPV1042\nPV2037\nPV2038\nPV2011\nPV0894\nPV2013\nYP5031-Centricity Enterprise Archive-02332513\nPV2014\nPV1045\nPV5020\nYP5037-Centricity Enterprise Archive-15349246\nPV2012\nYP5021-Centricity Enterprise Archive-02183759\nPV2008\nYP5026-Centricity Enterprise Archive-02253243\nYP5033-Centricity Enterprise Archive-02399307\nPV2051\nPV0892\nPV1052\nPV5022\nYP5022-Centricity Enterprise Archive-02285740\nPV2054\nPV2055\nPV5021\nPV1035\nPV2022\nYP5034-Centricity Enterprise Archive-14194564\nYP5038-Centricity Enterprise Archive-16450969\nYP5045-Centricity Enterprise Archive-20509114\nPV2053\nPV0860\nPV0903\nPV1027\nPV1051\nPV2043\nPV1061\nYP5042-Centricity Enterprise Archive-20101282\nYP5030-Centricity Enterprise Archive-02273408\nPV0877\nPV2028\nPV0490\nPV2026\nYP5035-Centricity Enterprise Archive-15111124\nPV1226\nPV2025\nPV2057\nPV1062\nPV1020\nYP5048-Centricity Enterprise Archive-20644651\nPV1064\nPV2058\nYP5039-Centricity Enterprise Archive-19630030\nPV5010\nYP5023-Centricity Enterprise Archive-02256895\nPV2031\nPV2015\nPV0873\nPV2052\nYP5019-Centricity Enterprise Archive-02042637\nYP5036-Centricity Enterprise Archive-15261449\nPV2029\nPV2007\n0850550152\n0850550196\n0850550314\n0850550115\n0850550316\n0850550321\n0850550139\n0850550238\n0850550296\n0850550298\n082S129003\n0850550249\n0850550140\nKW1155PC11\nKW1157PC05 - RAD EA\nKW1163PC05\nKW1102PC02\nKW1011PC07\nKW1012PC04\nKW1155PC16 - CVIT EA\nKW1018PP03\nKW1020PC01\nKW1163PC07-CVIT EA\nKW1096PC04\nKW1018PC21\nKW1018PC16\nKW1098PC01\nKW1004PC03\nKW1007WS06\nKW1001PC09\nKW1019PC02 - CVIT\nLB1485PC03\nLB1001PC09\nLB1160PC02\nLB1000PC04\nLB1462PC02\nLB1497PC09\nHUSM010\nUMMC-EA4\nCVSKL-EA\nTBA-EA_4448076_96\nCENGILD-EA\nPSH-EA\nMMC8\nMMC-EA-Shadow\nHSB-EA\nREGENCY-EA4\nPKHS-EA\nLifecare-EA\nHospital Sultan Abdul Halim, Sungai Petani_EA\nPahang Karak Health Clinic\nIIUM-EA\nAMPANG2\nSERDANG2\nMediliance01\nSGB-EA\nHPU-EA\n01301460\nHCIT4579183EA\nHCIT4753028EA\nHCIT4825663EA\nHCIT4865124EAnew\nHCIT4784198EALTS\nHCIT4784198EADB\nHCIT4753028EA\nHCIT4820102EA\nHCIT4665855EA\nHCIT4865124EA\nHCIT4753028EALTS\nAMS3961\nASS0160\nNot Available\nTo be defined\nTo be defined\nTo be defined\nTo be defined\nTo be defined\nTo be defined\nTo be defined\nTo be defined\nTo be defined\nOM1109PC07\nOM1109PC06\nHCIT5109010EA\nHCIT5109010EA2\nHCIT4369313EA\nHCIT4714397EA\nHCIT1693543EALTS\nHCIT1693543EALTS2\nHCIT1693543TESTEA\nHCIT1693543EAMIG\nHCIT4274455AEA\nbackupGD2\nAFFIDEA24838968\nbackupkal\nTBD\nAFFIDEA24840214\nAFFIDEA25205462\nPL1426PC01\nTBD\nbackupols\nNot Available\nAFFIDEA25205463\nAFFIDEA24834222\nAFFIDEA24839746\nSiteID-Centricity Enterprise Archive-20571215\nPL3277RW02\nPL3249PC01\nPL1674PC01\nPL1943PC01\nPL3192RW02\nAFFIDEA22171731\nSZASEROW24442162\nTBC\nSiteID-Centricity Enterprise Archive-20094759\nPL1644PC01\nNot Available\nAFFIDEA20650372\nAFFIDEA25205864\nAFFIDEA24836050\nAFFIDEA25205465\nTBD\nPER50334\nTo be defined\nTo be defined\nTo be defined\nTo be defined\nQA1102PP01\nQA1015PP05\nQA1015PP06\nRODATBV-EA01\nRU1934ID01\nRU8902ID01\nRU3152ID01\nRF1194ID02\nRF0048ID01\nRU7645ID01\nRU8776RW01\nRU1011ID03\nRU1648RW01\nRU3453RW02\nRU9617ID01\nRU0472ID01\nRU7361ID02\nRU8356RW01\nRU3232ID02\nN/A\nRU1733ID01\nRU3756ID02\nRU2527RW01\nRF3071ID01\nRF3031ID02\nRF1647ID03\nRU7950ID01\nRU1516ID01\nRU8271ID01\nRF0827ID01\nRU1857ID02\nRU8189ID02\nRU9227ID01\nRU9333ID01\nRU1112ID03\nRU1717ID03\nRU1192RW01\nRU2751RW01\nNot Available\nRF2557ID01\nRU7021ID02\nRU1757ID01\nRU3192ID01\nRU2966ID01\nRU1095ID02\nRU3143ID05\nRU3052ID02\nRU9000ID03\nNot Available\nNot Available\nNot Available\nNot Available\nNot Available\nRU1128ID01\nRU6265ID02\nRF1085ID02\nRF1085ID04\nRU9515ID01\nRF1203ID02\nRU2665ID02\nRU3896ID02\nRU3158ID01\nNot Available\nNot Available\n600101RW01\nRU2050ID03\nNot Available\nRF0001ID01\nRF0001ID10\nRU9594ID02\nRU2636ID01\nRU8615ID01\nRU1377ID01\nRU1052ID01\nNot Available\nRU1026RW01\nRU2526ID01\nRU9940RW01\nRU8412ID01\nRU0994ID01\nRF0929ID01\nRU1473ID01\nRU3468ID02\nNot Available\nRU9383ID01\nRF1383ID03\nRU1140ID01\nRU7834ID01\nRF2412ID01\nRU1143ID02\nRU1449ID01\nRF3761ID01\nRU7579ID01\nRU3427ID03\n600105ID01\nRU0968ID02\nRU8796ID01\nRU8782ID01\nNot Available\nRU8151RW01\nNot Available\nRU1152ID01\nRU1999ID01\nRU3998ID02\nNot Available\nRU0912ID01\nSA2591PP03\nSA1060_CARD\nSA2410PP08\nSA1039PP11\nSA2433PP04\nSA2385EA01\nSA2329PP - EA LTA\nSA1005PPEA - CARD\nSA1005PP08 - RAD\nSA1176CCA\nSA1025EA\nSA2110_EA_LTA\nSA1209PP12\nSA1008PP15_EA_PROD\nSA1008_EA_TEST\nSA1001_EA_PROD\nSA2191_EAGW\nSA2393EA01\nSA2006PP06\nSA1175\nRADLINK12\nNot Available\nTTSH-CVIS-EA-PROD\nTo be defined\nU-1ERQRC20606142\nZA2103PP01\nZA2874PP01\nZA2241PAC5\nZA2812PAC6\nZA2151PAC4\nZA2917EA01\nza000000\nMPX43143\nNE465132\nNE465122\nNE670337\nNE670327\nNE673148\nNE673139\nNE300618\nNE219652\nNE219646\nNE219690\nFEG51832\nFEG51833\nMEX70165\nMEX25581\nMEX689420\nMEX689439\nMEX689482\nMEX689483\nMEX689484\nMEX689485\nMEX617118\nGPQ13905\nDEN272119\nDPN29615\nDPN29616\nDE993856\nNPV73815\nNPV73806\nNPV73807\nNE203154\nNE203143\nNE203144\nNE740530\nNE216236\nNE216227\nNE216228\nNE487836\nNE487828\nFPD10808\nFPD10831\nDE5392100\nDE539284\nDE539293\nNot Available\nNE723615\nNEV07038\nNEV44302\nMED09301\nNE748623\nNE748616\nNEV13629\nNEV13620\nYE645875\nNEV06840\nNEV06841\nNE304916\nNE419153\nNPV84530\nNE223257\nNE223247\nNE419142\nNE419143\nNPV84523\nNPV84524\nNEV439277\nNot Available\nC99999302\nNE741447\nNE741439\nNEV35828\nNEV35829\nNE688828\nNE688829\nUP285A31\nGEE34099\ntobecreated\n150010EA01\n475290PC04\nNot Available\n315258PC01\n730140PC01\n150080PC01\n0853550820\n0853550867\n0853550142\n0853550260\n0853550871\n0853550983\n0853550804\n0853551073\n0853551073\n0853550616\n0853550993\n0853550902\n0853550869\n0853550276\n0853550993-Centricity Enterprise Archive-20680151\n0853550201\n0853550772\n0853550218\n0853550421\n0853550000\nRAMATHIBODI04\nCHONBURI02\nKKU-EA\nHCIT4783733EA\n06051PAC09\n06680PAC04\n06162PAC02\n06051PAC02\n06002PAC31\n06008PAC01\n06002-CARDEA\n34696PAC03\n34365PAC01\n34893PAC02\n34361PAC02\n34225PAC08\n34412PAC02\n34435PAC03\n34433PAC02\n34340PAC05\n41400PAC04\n48010PAC06\n06004PAC26\n59025PAC03\nEA23.5\nAE0002PP07\nAE1802PP03\nAE1564PP07\n01888407\n60638EA002\n60116EA001\nCRHCARDEA01\n60044ARM02\ntbc\nKGHCCWEA\nNot Available\n80257RJF02\n80257RJF01\nRTGAIM30\nEDLC_EA_Univ_Hosp_Leicester\nEDLC_EA_EMRAD_Kettering_General\nNot Available\nWSEA01\nRBK0200101\nWalsall24399361T\nHCIT5125353EA\nHCIT4210533EA\nHCIT4268589EA\nUZ1307ID01\nBacLieuGH-EA\nBacLieuGH-NB-EA\nPhuongChauCanTho-EA\nVINMECDN09\nTHUCUCIGH01\nVINMECHAIPHONG09\nVINMECINT-EA\nVINMECTANCANG-EA\nCIH-EA\nVINMECNHATRANG09\nVINMECPQ9\nNINHBINH004\nTHANHNHAN03\nNCH-EA\nSAIGONITO01\nTDMEDICAL01\nTDMEDICAL-EA\nXuyenACuChi-EA4\nVINMECHL09", "firm_fei_number": "3004526608", "recalling_firm": "GE Healthcare", "address_1": "500 W Monroe St", "city": "Chicago", "state": "IL", "postal_code": "60661-3671", "additional_info_contact": "GE HealthCare Service\n800-437-1171", "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.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/26 was sent to customers.\n\nActions to be taken by Customer/User\nPending corrections from GE HealthCare, you can continue to use your systems by following the instructions below.\n1. Do not perform any new inbound data (DICOM) migration projects. Please contact GE HealthCare before starting any new migration projects.\n2. 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:\nAt the Study level:\n\" 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.\n\" If burned-in or embedded patient identifiers are not available, compare with prior studies based on patient anatomy, implants, or unique anatomical features.\nAt the Image level:\n\" Confirm that the images within the study do not belong to different patients based on acquisition date and time or other patient identifiers.\nPlease maintain any previous source systems or migration servers pending correction of this issue by GE HealthCare.\nPlease ensure that all potential users in your facility are made aware of this safety notification and the recommended actions above.\nPlease retain this document for your records.\nPlease 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.\nIf you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "1856 systems", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K082041", "K994270", "K111776", "K153091", "K173512", "K183105", "K061035", "K241608", "K173939", "K051840", "K913754", "K030276", "K063505", "K093234", "K003484", "K221499", "K990241", "K162574", "K052958", "K083910", "K220832", "K061472", "K972520", "K051528", "K103554", "K961740", "K212758", "K192435", "K111642", "K230016", "K122536", "K092125", "K232007", "K061160", "K140139", "K972215", "K971776", "K063628", "K092842", "K954222", "K984023", "K141451", "K082483", "K081076", "K043194", "K993338", "K171130", "K211356", "K101796", "K150747", "K250800", "K033088", "K183012", "K232456", "K090218", "K080351", "K080334", "K063066", "K162484", "K150069", "K232589", "K971714", "K252526", "K073194", "K073418", "K072960", "K192304", "K101398", "K143290", "K182130", "K181939", "K092204", "K222975", "K242556", "K052337", "K032760", "K023936", "K915237", "K253899", "K162830", "K002597", "K023339", "K141881", "K082496", "K021191", "K242810", "K971965", "K122164", "K132342", "K143044", "K170250", "K102150", "K093247", "K180916", "K020073", "K170729", "K111052", "K181825", "K180883", "K992925", "K120525", "K171053", "K023460", "K091001", "K983111", "K152009", "K040142", "K040040", "K031248", "K121517", "K092954", "K233634", "K141669", "K183164", "K082596", "K032533", "K222069", "K954678", "K123575", "K060267", "K142919", "K220727", "K082430", "K082441", "K151941", "K941933", "K091364", "K954589", "K231360", "K250301", "K130770", "K083691", "K133654", "K211713", "K103565", "K072952", "K191125", "K170793", "K190767", "K240822", "K141199", "K182815", "K051901", "K143254", "K900697", "K121916", "K181773", "K172477", "K191216", "K051081", "K103679", "K152172", "K230906", "K000015", "K110447", "K141364", "K032202", "K063037", "K882205", "K001748", "K993750", "K210916", "K052460", "K050736", "K970617", "K123922", "K110494", "K123519", "K230856", "K885318", "K162008", "K172998", "K852284", "K140337", "K031836", "K191262", "K023877", "K173329", "K023190", "K162011", "K151438", "K092581", "K955185", "K080890", "K172168", "K140860", "K011582", "K210682", "K893521", "K040982", "K864739", "K163250", "K103576", "K082526", "K221065", "K031013", "K953164", "K001752", "K863132", "K201202", "K051853", "K062490", "K070370", "K072986", "K160317", "K172346", "K113844", "K021099", "K070796", "K193403", "K212981", "K854810", "K171544", "K260009", "K001550", "K032096", "K112354", "K041366", "K071362", "K202519", "K103687", "K200546", "K983529", "K002039", "K090050", "K051392", "K141561", "K103308", "K040195", "K222987", "K260231", "K123901", "K113701", "K123174", "K131685", "K120361", "K082607", "K161148", "K251577", "K963610", "K031567", "K233176", "K233714", "K100784", "K261916", "K072065", "K070618", "K122429", "K182034", "K053155", "K150313", "K203783", "K230196", "K031372", "K220039", "K153073", "K042868", "K141554", "K993283", "K182926", "K143079", "K191188", "K844298", "K024137", "K974504", "K083018", "K070803", "K033859", "K163076", "K113029", "K862309", "K161959", "K081512", "K062743", "K032483", "K973835", "K031886", "K081109", "K052529", "K131389", "K081630", "K241223", "K932372", "K093117", "K110332", "K232339", "K031704", "K143586", "K935694", "K091274", "K243209", "K253784", "K223363", "K964124", "K101654", "K231041", "K123023", "K210931", "K945188", "K223841", "K192923", "K131158", "K081347", "K041270", "K131447", "K901679", "K111991", "K023003", "K040697", "K152661", "K133367", "K941093", "K192348", "K162141", "K903196", "K974207", "K222470", "K962260", "K123526", "K013994", "K203677", "K042995", "K151075", "K143176", "K163119", "K242838", "K200703", "K081948", "K180125", "K161188", "K063153", "K133521", "K210187", "K001140", "K140797", "K922267", "K202292", "K872455", "K081262", "K052411", "K241989", "K081215", "K953095", "K022881", "K902648", "K132587", "K180867", "K042353", "K071492", "K131090", "K142750", "K963859", "K053133", "K844783", "K952313", "K082269", "K040050", "K081242", "K202212", "K173897", "K090649", "K161685", "K250716", "K253950", "K152352", "K230044", "K231607", "K020658", "K042203", "K161601", "K150085", "K262143", "K190042", "K993227", "K132095", "K965179", "K925465", "K042781", "K844784", "K123970", "K110875", "K925963", "K163071", "K151837", "K142521", "K062650", "K093703", "K240839", "K090607", "K111019", "K211443", "K012097", "K200589", "K221677", "K244016", "K250664", "K262462", "K111079", "K170167", "K151988", "K983392", "K112096", "K013630", "K060136", "K992306", "K082493", "K970964", "K982120", "K120305", "K153427", "K020140", "K041581", "K240294", "K993530", "K124051", "K081168", "K003459", "K173054", "K991738", "K142196", "K251030", "K022940", "K171435", "K202793", "K050943", "K132742", "K152186", "K033825", "K081556", "K063267", "K192038", "K161341", "K231503", "K040227", "K253486", "K173247", "K163533", "K982563", "K252608", "K071000", "K954159", "K982769", "K101324", "K242362", "K973653", "K073292", "K061018", "K030242", "K861429", "K070726", "K223502", "K061418", "K012093", "K052461", "K163290", "K032176", "K101898", "K122329", "K191026", "K113419", "K110414", "K142037", "K112387", "K052775", "K042867", "K192109", "K201665", "K980970", "K062237", "K083658", "K112679", "K963980", "K192743", "K140897", "K221511", "K041500", "K103475", "K040028", "K132763", "K123269", "K024358", "K043216", "K251863", "K123302", "K010571", "K173605", "K060505", "K071636", "K063327", "K063269", "K173622", "K042634", "K072665", "K253831", "K012086", "K192531", "K042313", "K200899", "K252195", "K161841", "K122022", "K874865", "K041162", "K253111", "K973065", "K223909", "K223048", "K083084", "K900586", "K983088", "K033093", "K990052", "K033712", "K151850", "K243703", "K232100", "K072875", "K212230", "K193523", "K844037", "K163668", "K052312", "K193294", "K081402", "K110033", "K060263", "K123420", "K113082", "K152822", "K000557", "K242512", "K210999", "K113620", "K223180", "K152716", "K201632", "K081093", "K200179", "K102684", "K012844", "K000014", "K132963", "K142923", "K070755", "K133984", "K891695", "K221463", "K162541", "K230803", "K063266", "K162799", "K955092", "K043350", "K110077", "K053458", "K053281", "K050341", "K260588", "K040305", "K191959", "K162743", "K152949", "K091687", "K071054", "K120734", "K232862", "K182643", "K182572", "K200750", "K992886", "K050619", "K982862", "K151687", "K121213", "K130383", "K032186", "K082228", "K222054", "K092235", "K222195", "K932371", "K100881", "K160937", "K042292", "K110300", "K936179", "K160914", "K181460", "K111373", "K151913", "K171115", "K223660", "K023533", "K945807", "K110844", "K210071", "K062878", "K032924", "K170747", "K210136", "K003607", "K260576", "K072728", "K233582", "K132799", "K053347", "K211156", "K210072", "K083348", "K032638", "K192888", "K181264", "K242552", "K092915", "K241694", "K032555", "K101166", "K222854", "K233660", "K053043", "K250120", "K063439", "K082336", "K111161", "K103792", "K041782", "K861279", "K103761", "K173420", "K203287", "K183272", "K023772", "K133708", "K142514", "K182750", "K151568", "K051649", "K061396", "K073306", "K163048", "K041078", "K070464", "K150707", "K073007", "K082386", "K061532", "K041990", "K092519", "K240620", "K121466", "K110886", "K061303", "K030457", "K133730", "K080457", "K073358", "K081018", "K100335", "K130772", "K213562", "K110511", "K111892", "K081792", "K111731", "K920309", "K223336", "K082628", "K231396", "K033005", "K060378", "K071964", "K012327", "K043333", "K071894", "K081055", "K133910", "K111641", "K202229", "K990442", "K081672", "K971290", "K161515", "K232661", "K070248", "K090732", "K090155", "K123650", "K133644", "K982820", "K924310", "K000291", "K241350", "K172239", "K162727", "K050993", "K050485", "K160579", "K120514", "K120995", "K221680", "K892397", "K061947", "K123082", "K143319", "K972933", "K103181", "K971973", "K162112", "K081308", "K182537", "K152746", "K052276", "K052344", "K952862", "K202256", "K250686", "K971368", "K092363", "K013574", "K941566", "K072637", "K160284", "K100619", "K160376", "K171356", "K001947", "K091160", "K181892", "K102148", "K963697", "K080951", "K120709", "K243069", "K140869", "K242599", "K241300", "K022292", "K243651", "K022710", "K203142", "K083332", "K010938", "K130103", "K092613", "K111660", "K262060", "K163158", "K051037", "K021669", "K133966", "K012155", "K031778", "K151957", "K100236", "K033400", "K173001", "K213215", "K163285", "K230955", "K212685", "K041935", "K120196", "K090461", "K063846", "K171068", "K042660", "K200132", "K172218", "K220779", "K231162", "K080770", "K203651", "K192692", "K130159", "K112604", "K062905", "K923042", "K111990", "K121074", "K090295", "K132316", "K952778", "K120161", "K082135", "K071436", "K152078", "K030781", "K203195", "K042212", "K260479", "K230854", "K261352", "K131348", "K153346", "K011173", "K012439", "K141329", "K223820", "K121387", "K970349", 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