BEUDAMED
    FDA Recall Open, Classified

    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

    Recall: Z-0140-2024 · Initiated September 14, 2023

    Recall

    Recall Number
    Z-0140-2024
    Event Number
    93099
    Firm
    GE Healthcare
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 14, 2023
    Posted
    October 20, 2023
    Address
    500 W Monroe St, Chicago, IL, 60661-3671

    Description

    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

    Reason

    GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

    Action

    GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/14/2023 by letter. The notice explained the problem, risk to the patient, and provided two workaround options for the continued use of the instruments until the software update is ready for installation. Questions: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative

    Distribution

    US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam

    Quantity

    329 units