FDA Device recall Z-1533-2021
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images…
- FDA Device
- Class II
- terminated
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images… by Ge Healthcare, citing when the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient j….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1533-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-19 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Reason
When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
Identifiers
| code_info | UDI: 00840682145794; Serial Numbers: 105906-2-Centricity Universal Viewer-02312613; 6100002127; 4049-1-Centricity Unive…UDI: 00840682145794; Serial Numbers: 105906-2-Centricity Universal Viewer-02312613; 6100002127; 4049-1-Centricity Universal Viewer-00104520; 4049-1-Centricity Universal Viewer-00104521; 4049-1-Centricity Universal Viewer-00104522; 6100003887; 9619-c23f-0fae-4eb2-95f8-1529-7e0f-cb89; 103835-2-Centricity Universal Viewer-01370706; 103835-2-Centricity Universal Viewer-01370707; 103835-2-Centricity Universal Viewer-14549671; 103835-2-Centricity Universal Viewer-19676013; 103835-2-Centricity Universal Viewer-19676014; 103835-2-Centricity Universal Viewer-19676015; 103835-2-Centricity Universal Viewer-19676016 103835-2-Centricity Universal Viewer-19735426; 1ec2-1d6c-8e6b-4261-a436-2190-812d-b5df; 10388-1-Centricity Universal Viewer-14762267; 10388-1-Centricity Universal Viewer-17744828; 10388-1-Centricity Universal Viewer-17744829; 10388-1-Centricity Universal Viewer-17744830; 10388-1-Centricity Universal Viewer-17744831; 10388-1-Centricity Universal Viewer-19661410; 6100003912; 4642- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1533-2021%22
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