FDA Medical devices recall ·
Enterprise Archive V8, software product for receiving, archiving… recall
- Recall number
- Z-3167-2026
- Date
- (initiated July 31, 2026)
- Company / brand
- GE Healthcare
500 W Monroe St, Chicago, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1298 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: V4 - 00195278409287; System IDs: BIRMINGHAM20886386 SevierCou21180101 SevierCou21180111 UOAR24851211 UOAR23214501 CARTI27326017 KGM21766613T KGM21332085 KGM21677289 HRH323169307 HONORHEALT21179400 MIHS25042933 MIHS25151161 MIHS25042933 MIHS25151165 MIHS25151166 ADHR27301883 PMIO26874972 PMHD27236488 PIPELINEH26974662 PIPELINEH27011598 SANFERNAN23238694 KRM22180898 MHL23269965 SUTH26668887 NORV21741298 24931893EdgeEA 25083358StgEdgeEA VCM27268846 SCRL24283967 SCRL23202147 SFGH24285530 USHC25292971 USHC26580362 GSH321314340 LosRobles23253832 QTHBL26325570 DENVERVA21733821 DENVER VA24406115 BOULDER22107026 BOULDER22107318 BOULDERCO24954910 HHL27121414 Not Available GRHD20869082A GRHD20869563B GRHD20870041T GRHD27231932 Not Available VVMC21290279 VVMC24397815 VVMC23203058 DDOC26923413 BAYHEALTH22212474 BAYHEALTH23201150 BAYHEALTHxxx BAYHEALTH26871762 JFKR20875123CEAGW 100029-1-Enterprise Archive-27124494 106428-3-Enterprise Archive-21313581 BYH24954908 BYH26856929 BYH26856932 LMC421600077 MH820838229 BIHT21020972 BIHT21305845 BIHT21305846 BIHT21305854 BIHT21305855 BIHT21305856 BIHT21310361 MH826770189 KRMC22464526 KRMC23157942 OFMC22161730T OFMC23066623P ORDC20944523 ORDC21315028 WELLINGTON27007867 RMCB23599904 PALMBEACH26587094 PALMBEACH26668888 AMCL21358642 CRMC21017209 HLEEMOFF21248284 HLEEMOFF21248387 HLEEMOFF21248397 BYH26649265 BYH26705437 BYH26782652 BYH26782654 WELLINGTON24453857 WELLINGTON24608353T LAKESIDEM21200034 LAKESIDEM21728988 WELLINGTON NEUROSKEL22629459
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3167-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.