medical Class II Updated 2021-05-12

GE Healthcare, LLC recalls Centricity Universal Viewer - Product Usage: intended to as

Recalled Product

Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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; 4642-6-Centricity Universal Viewer-02255109; 4642-6-Centricity Universal Viewer-02255132; 4642-6-Centricity Universal Viewer-02255133; 4642-6-Centricity Universal Viewer-14580266; 4642-6-Centricity Universal Viewer-14580267; 2457-1-Centricity Universal Viewer-00108168; 3791-1-Centricity Universal Viewer-18836815; 3791-9-Centricity Universal Viewer-15291373; 3791-9-Centricity Universal Viewer-19172098; 6100003882; b1aa-a5a8-dacb-4a74-90ca-41af-c9ed-83dd; 6100003897; 3545-3-Centricity Universal Viewer-00096349; 3545-3-Centricity Universal Viewer-00096350; 3545-3-Centricity Universal Viewer-00158590; 3545-3-Centricity Universal Viewer-00158591; 3545-3-Centricity Universal Viewer-00158592; 3545-3-Centricity Universal Viewer-00158593; 3545-3-Centricity Universal Viewer-00158594; 3545-3-Centricity Universal Viewer-01546163; 3545-3-Centricity Universal Viewer-01764841; 3545-3-Centricity Universal Viewer-01800418; 1198-18-Centricity Universal Viewer-00116885; 1198-18-Centricity Universal Viewer-00116886; 1198-18-Centricity Universal Viewer-00116887; 1198-18-Centricity Universal Viewer-00116888; 1198-18-Centricity Universal Viewer-00116889; 1198-18-Centricity Universal Viewer-00116890; 1198-18-Centricity Universal Viewer-00116891; 1198-18-Centricity Universal Viewer-00116892; 1198-18-Centricity Universal Viewer-00116894; 1198-18-Centricity Universal Viewer-00116895; 1198-18-Centricity Universal Viewer-00116896; 1198-18-Centricity Universal Viewer-00116897; 1198-18-Centricity Universal Viewer-00116898; 1198-18-Centricity Universal Viewer-00116908; 1198-18-Centricity Universal Viewer-01370310; 41a1-fc8a-46c3-48c0-a90d-86fc-4d2e-5676; 100866-1-Centricity Universal Viewer-01287648; 100866-1-Centricity Universal Viewer-01287649; 100866-1-Centricity Universal Viewer-19611328; 100866-1-Centricity Universal Viewer-19611337; 100866-1-Centricity Universal Viewer-19611338; 100866-1-Centricity Universal Viewer-20021255; 100866-1-Centricity Universal Viewer-20021256; 100866-10-Centricity Universal Viewer-19611339; 100866-10-Centricity Universal Viewer-19611340; 100866-10-Centricity Universal Viewer-19611341; 100866-4-Centricity Universal Viewer-19660158; 4314-1-Centricity Universal Viewer-14640637; 4314-1-Centricity Universal Viewer-14776705; 4314-1-Centricity Universal Viewer-14776706; 4314-1-Centricity Universal Viewer-14776707; 4314-1-Centricity Universal Viewer-14776708; 4314-1-Centricity Universal Viewer-14776724; 6bc8-ba1a-6f59-4e1c-a6b8-98b2-7262-75dc; 103915-1-Centricity Universal Viewer-19669927; 6901-11-Centricity Universal Viewer-01974089; 6901-11-Centricity Universal Viewer-02354909; 6901-11-Centricity Universal Viewer-02354910; 6901-11-Centricity Universal Viewer-02354911; 6901-11-Centricity Universal Viewer-02354912; 6901-11-Centricity Universal Viewer-02354913; 7275-45-Centricity Universal Viewer-01891908; 7275-45-Centricity Universal Viewer-19665236; 7275-45-Centricity Universal Viewer-19665240; 7275-45-Centricity Universal Viewer-19665241; 7275-45-Centricity Universal Viewer-19665242; 7275-45-Centricity Universal Viewer-19665243; 7275-45-Centricity Universal Viewer-19665244; 6901-12-Centricity Universal Viewer-02354849; 6901-12-Centricity Universal Viewer-02354850; 6901-12-Centricity Universal Viewer-02354851; 6901-12-Centricity Universal Viewer-02354852; 6901-12-Centricity Universal Viewer-02354853; 6901-12-Centricity Universal Viewer-02354872; 6901-12-Centricity Universal Viewer-02354874; 6901-12-Centricity Universal Viewer-02354875; 6901-12-Centricity Universal Viewer-02354876; 6901-12-Centricity Universal Viewer-02354877; 3760-1-Centricity Universal Viewer-19605860; 3760-1-Centricity Universal Viewer-19727283; 3760-1-Centricity Universal Viewer-19727284; 283043-Centricity Universal Viewer-02285955; 283043-Centricity Universal Viewer-02339571; 283043-Centricity Universal Viewer-14766564
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