Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
FDA Recall Z-1533-2021 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2021-03-19
Date Terminated2023-08-11
Product Quantity112 units
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).
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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