Centricity Universal Viewer - Product Usage: intended recall
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other…
Why was Centricity Universal Viewer - Product Usage: intended recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 112 units
- Distribution
- Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada.
- Recall date
- May 12, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)