United StatesCentricity Enterprise Archive V2–V4 and Enterprise Archive V8; Centricity PACS V2–V4, V6–V7 and Centricity PACS Server V7; Workflow Core Services V8; and Core Services Hub V8 (all versions) — software used to receive, archive, store, view and manage digital medical images and patient data — are affected. They were recalled because, under certain conditions, historical imaging data migrated from a legacy system may become incorrectly associated with a different patient, causing studies or images to display under the wrong patient record and potentially leading to misdiagnosis or delayed care.
What's being recalled
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Centricity 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
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
Recalling firm: GE Healthcare, Chicago, IL, United States.
How to identify it
UDI-DI: 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…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)