Z-1533-2021Class II

Centricity Universal Viewer -

Name: Z-1533-2021 Centricity Universal Viewer -
Creator: GE Healthcare, LLC
Published: 2021-03-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-03-19 / Terminated

FDA source

GE Healthcare, LLC began a recall of Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information on 2021-03-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1533-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-19
Posted: 2021-05-05
Terminated: 2023-08-11
Recalling firm: GE Healthcare
Product: Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Product code: LLZ System, Image Processing, Radiological
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 root 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1533-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1533-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-12	2021-05-05

Product code LLZ

K182419Class IICentricity Universal ViewerGE Healthcare / cleared 2018-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)