FDA Device recall Z-3167-2026
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3167-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-31 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Reason
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.
Identifiers
| code_info | UDI-DI: V4 - 00195278409287; System IDs: BIRMINGHAM20886386 SevierCou21180101 SevierCou21180111 UOAR24851211 UOAR232145…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 LMC42 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Ge Healthcare
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Adminis…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise im…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3167-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.