BEUDAMED
    FDA Recall Open, Classified

    Universal Viewer Workflow Manager, Image processing radiological system

    Recall: Z-0143-2024 · Initiated September 8, 2023

    Recall

    Recall Number
    Z-0143-2024
    Event Number
    93053
    Firm
    GE Healthcare
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 8, 2023
    Posted
    October 23, 2023
    Address
    500 W Monroe St, Chicago, IL, 60661-3671

    Description

    Universal Viewer Workflow Manager, Image processing radiological system

    Reason

    When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

    Action

    GE Healthcare notified consignees on about 09/08/2023 via letter. Consignees were instructed that until the software update is available the device can still be utilized through an updated browser setting or through discontinuing the use of bi-directional reporting. A GE Healthcare representative will contact each consignee to arrange for the correction. Consignees were instructed to complete and return the provided acknowledgement response.

    Distribution

    Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.

    Quantity

    57 units