FDA Device recall Z-0140-2024
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1 by Ge Healthcare, citing GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0140-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-14 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Reason
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Identifiers
| code_info | UDI/DI 840682103800, Installed Product ID #: 102123-1-Centricity Universal Viewer-00558570, 102123-1-Centricity Univer…UDI/DI 840682103800, Installed Product ID #: 102123-1-Centricity Universal Viewer-00558570, 102123-1-Centricity Universal Viewer-02157634, 1011-1-Centricity Universal Viewer-00558109, 1011-1-Centricity Universal Viewer-02097166, 1011-1-Centricity Universal Viewer-02097165, 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 9789-1-Centricity Universal Viewer-00558645, 4413-2-Centricity Universal Viewer-02288447, 4267-5-Centricity Universal Viewer-19618406, 100763-1-Centricity Universal Viewer-00558366, 101171-1-Centricity Universal Viewer-02398531, 101171-1-Centricity Universal Viewer-02398531, 104535-3-Centricity Universal Viewer-02396026, 104535-3-Centricity Universal Viewer-02396027, 104535-3-Centricity Universal Viewer-02396028, 104535-3-Centricity Universal Viewer-02396029, 11438-1-Centricity Universal Viewer-00558464, 104535-4-Centricity Universal Viewer-02396030, 104535-4-Centricity Universal Viewer-01806096, 4415-1-Centricity Universal |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Ge Healthcare
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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 - Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0140-2024%22
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