Class 2 Device Recall Centricity Universal Viewer

• Date Initiated by Firm: March 19, 2021
• Create Date: May 05, 2021
• Recall Status: Terminated on August 11, 2023
• Recall Number: Z-1533-2021
• Recall Event ID: 87652
• 510(K)Number: K182419
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
• Code Information: 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
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 1800-437-1171
• Manufacturer Reason for Recall: 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).
• FDA Determined Cause: Under Investigation by firm
• Action: A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to the consignees on 03/19/2021 via letter. The letter instructs the consignee that they can continue to use the device by following the below safety instructions: "1. Visually verify that the patient demographic information for all comparison exams when hung in the Image Viewer match that of the primary patient under review. 2. If you encounter comparison exams that do not belong to the primary patient under review, close the primary exam and reopen the exam from Workflow Manager." The consignee is also told to destroy the installation media for the affected software once a GE Healthcare representative has updated the system.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ and Original Applicant = GE Healthcare