BEUDAMED
    FDA Enforcement Class II Ongoing

    Universal Viewer Workflow Manager, Image processing radiological system

    Recall: Z-0143-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0143-2024
    Event ID
    93053
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 1, 2023
    Initiation Date
    September 8, 2023
    Classification Date
    October 23, 2023
    Address
    500 W Monroe St, N/A, Chicago, IL, 60661-3671, United States

    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.

    Code Info

    UDI/DI 00195278379610, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted.

    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