GE Healthcare recalls Centricity Enterprise Archive V2
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
Lot / code information
- UDI
V4 - 00840682102766; System IDs: CARTI02312615 CARTI22225617 520784EASFTW1 19233337_EA MARICOPAC02308032 602406SAEAFSW 602997SAEASW-24 SVRHC14765622 520458CVEASW 520780SAEASW 520784EASSASW 520629EA1 B…Show all
V4 - 00840682102766; System IDs: CARTI02312615 CARTI22225617 520784EASFTW1 19233337_EA MARICOPAC02308032 602406SAEAFSW 602997SAEASW-24 SVRHC14765622 520458CVEASW 520780SAEASW 520784EASSASW 520629EA1 BERMUDACA02257222 BERMUDACA02257223GW ASHPACSEA1P 805395EASW PMHD15081203 805725EASW1 V5SPORTS01804915 559582CAEASW 760775CAEASW 310673CAPACSSW UHVNAEAPRD01 UHEAVNATEST01 UHVNAEAPRD02 UHVNAEAPRD03 UHVNAEAPRD04 UHVNAEAPRD05 UHVNAEAPRD06 310349EASW1 310349EASW2 310349EASW3 310ODCEASW4 ADVENTIST02256061 323726CAEASW NDMGCAWEB PALMDALEM02354935 PALMDALEM19604722 PALMDALEM19604723 661948ISBSW 818676EA01 916781MMBSW1 916781MMBSW2 ADVENTIST1474489 SUTH20087395 707554EASW 916733EASTSW1 916733EASTSW2 916733EASTSW3 916733EASTSW4 916733EASTSW5 916733EASW2 916733EASW3 916733EASW4 916733EASW5 916733SAEASW SUTH20992909 SUTH20992910 SUTH20992912 SUTH20992914 650696EASW 408590EAAIMSW 805542SAEASW VSMY01820424 VCM01983687 SONORAREG26747425 RANCHO02255035 RANCHOTEA01 RANCHODTEA01 UHS24494273 VCM01819620 CWHMC01821420 303584CVEAFSW 303584EASW3 303584EASW1 303715CVEASW GRHD16174555 203384CAEASW 202745CAEASW 302674CCASW 01730933BAYHEALTH JFKR21743924 LAKESIDEM02275735 727462EASW 772468EASW-SAAIM2 EFDVWPTCMAIM04 352333AIMEASW 352331EACCASW 352331EASW BIHT22108325 BHIT11111111111111 ORMC320536538 LARGOMEDI24412138 305223EASW-SAAIM2 DAVIEMEDI20960878 305223EASW-SAAIM3 239860SAEASW 352237CVEASW UCFNONAL20037311AWEA PCMC4-20940705 850494EASW 904819EASW1 904819EASW2 941342EASW HRMT19664009-AIM01 888663AFEASFTW3 VSMAF02345970 BYH02360323EA1 MCC15961440EA NORTHE14610617 BYH14776394AIM1 BHY14776395AIM2 BHY14776396AIM3 BHY14776397AIM4 BYH14929313EA2 BYH14929315EA3 813971ECVPACS 954688EASUV100 NGDC01893571 813873CASAEASW HLEEMOFF21014281 HCAWESTF24284158 BYH26758983CCAEA6 BYH26758991CCAEA7 TRMCN19965352 901392EASW TRMC-21771222 407777EASWT 407777EASW1 407777EASW4 21300644EASW 21301799EASW 21301800EASW 21301807EASW5 706651CVEASW 706596CAEASW 912276EASW 706272CCABSW HMC720996757T 404501EASW1 404501EASW2 706754EA1SW 404605SFEASW 404605EASW 406238EASW VSMZ01812194 319388EADBT 641422EASW CWVM24336377 IFCH02344193EAAPPTEST IFCH02368939EAAPP IFCH02369613EA2APP 847618EASW1 847618EASW2 26832372EATest ANNROBE19660175 ANNROBE19660178 RPS19736388 RPS19736389 773880EASW1 773880EASW2 795079OEASW 795079REASW 312996SAEAAIM01 RCTI01804917 312996SAEAAIM02 815285EASUV100 ALEXIAN02173643T 847657EADBT 708202CVEASW 847ABEASW 847SAEASW LaitekDataMigrationCPACSLabEA 309962SSASW_EA 618436EASW S046EASW2 S801EASW1 GSRHC22096532 S801EASW1A AAHCPACSARCHP2APPN1 AAHCPACSARCHP2APPN2 PIPELINEH19666526CCAT PIPELINE19666739S2 PIPELINEH19666740CCAN1 PIPELINEH19666741CCA 815824EASUV100 MPAL1454994 ADVPACSAIM151 ADVPACSARCHT1 ADVPACSARCHT2-NEW AAHCPACSARCHP1APPN1 AAHCPACSARCHP1APPN2 ADVPACSAIM87 630963AIM151 ADVPACSAIM58 ADVPACSAIM86 ADVPACSAIM101 ADVPACSAIM102 ADVPACSAIM61 ADVPACSAIM59 ADVVNAAIM192 ADVVNAAIM193 ADVPACSAIM145 ADVVNAAIM194 ADVVNAAIM003 815398EASW 847657SAEASW 765561SAEASW LRHS19716184 765983EASW THRH20280221 316706EASFTW 502226EASW-EAPROD FRMC22295734 606439CAPACSSW 606679CAEASW RRMC120606244 985230EASW-EA82 PACSEAT1 985785EASW CFO18227237 985LVWEASW 504380CAEASW HTMC23300064-AIM OVERTON20031487 318221CAEASW 337527CAEASW TRM20095296 TRM20095297 PHS20915074 PHS20915379 PHS20915380 PHS20915381 PHS20915382 PHS20915383 PHS20915384 PHS20915385 PHS20915386 PHS20915387 PHS20915388 PHS20915389 PHS20915390 PHS20915391 PHS20915392 978937CAPACSSW TLGH24854574 PHS16023953 PHS20915339 PHS20915340 PHS20915341 PHS20915342 PHS20915343 PHS20915344 PHS20915345 PHS16023953 PHS20915347 PHS20915348 PHS20915349 PHS20915350 PHS20915351 PHS20915352 PHS20915353 PHS20915354 PHS20915355 PHS20915356 PHS20915357 PHS20915358 PHS20915359 PHS20915360 PHS20915365 PHS20915361 PHS20915362 PHS20915363 PHS20915364 PHS20915366 PHS20915367 PHS20915368 PHS20915369 PHS20915370 PHS20915371 MDCVPAPP31 MDCVPAPP32 MDCVPAPP33 MDCVPAPP34 MDCVPAPP35 MDCVPAPP36 MDCVPAPP37 MDCVPAPP38 MDCVPAPP39 MDCVPAPP40 MDCVPAPP41 MDCVPAPP42 MDCVPAPP43 MDCVPAPP44 MDCVPAPP45 MDCVPAPP46 MDCVPAPP47 MDCVPAPP48 MDCVPAPP49 MDCVPAPP50 781979EASW1 781979EASW2 MELROSEWA20583692 978686EASW EACCA02041028 EACCA20915282 EACCA20915283 EACCA20915284 EACCA20915285 EACCA20915286 EACCA20915288 EACCA01601430 EACCA20915316 EACCA20915317 EACCA20915318 EACCA20915319 EACCA20915320 EACCA20915321 EACCA20915322 EACCA20915323 EACCA20915324 EACCA20915325 EACCA20915326 EACCA20915327 EACCA20915328 EACCA20915329 EACCA20915330 EACCA20915331 EACCA20915332 EACCA20915333 EACCA20915334 EACCA20915335 EACCA20915336 EACCA20915337 NDHMVPAPP20 NDHMVPAPP31 NDHMVPAPP32 NDHMVPAPP33 NDHMVPAPP34 NDHMVPAPP35 NDHMVPAPP36 NDHMVPAPP37 NDHMVPAPP38 NDHMVPAPP39 NDHMVPAPP40 NDHMVPAPP41 NDHMVPAPP42 NDHMVPAPP43 NDHMVPAPP44 NDHMVPAPP45 NDHMVPAPP46 NDHMVPAPP47 NDHMVPAPP48 RSCHVPAPP09 NDHMVPAPP49 NDHMVPAPP50 RSCHVPAPP01 RSCHVPAPP02 RSCHVPAPP03 RSCHVPAPP04 RSCHVPAPP05 RSCHVPAPP06 RSCHVPAPP07 RSCHVPAPP08 RSCHVPAPP10 RSCHVPAPP11 RSCHVPAPP12 RSCHVPAPP13 RSCHVPAPP14 RSCHVPAPP15 781344EASSA BERH02265911T 413447EASW2 413447EASW3 781624SAEASW1 410328SAEASW FMH21296028 FMH21296040 NORTHE02315656 269245SAEASW 313745CAPACSSW3 517353EASW 906387EASW 248858EASW 586573SSAEA 850912EADBTSW 651859EASW1 651859EASW2 651859EASW3 417820SAEASW 417312SAEASW 417269CAEASW 662624EASW VSMP01454845 228497CAEASW ROH19600630 601200RDMSEA2 601200EASW1 601200EASW2 601376EASW1 601376EASW2 601936EASW SCRMC20483088EASW 601426CAEASW 228497CAEATSW 601833EASW 406237EASW2 BC14767334EASW3 BC14767335EATSW 828326EASW1T02339893 CTV20092639 828326EACCASSW 828326EASW1 828326EASW2 CTV01440395 BJRH01458274 402484EASSW 402484EASW 22195055EASWT CTH19661473 603669SAEASW CTH22220612 CTH24306635T BLH01451962 BLH23256939 BLH23257090 BLH23257099 BLH23257110 SHS301815017 SHS320686077 ACMC102040128 609652CCASW 201568SAEASW VTH24285546 VTH24285547 VTH24285548 VTH24285549 VTH24285550 VTH24285552 VTH24336370 VTH24336371 856342EACCAUBS 856342EACCASSW RFP20892096 RFP20892098 RFP20892099 RFP20925842 RFP20925844 973754CAEASW 9737 …
What the firm is doing
An 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.
DistributionShow detailsHide
Worldwide - US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3166-2026
- FDA 510(k) clearance · K043415The device's official FDA premarket clearance record
- FDA 510(k) clearance · K110875The device's official FDA premarket clearance record
- FDA device classification · LLZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.2050The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find GE HealthcareSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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