BEUDAMED
    FDA Enforcement Class II Ongoing

    ViewPoint; system, imaging processing, radiological

    Recall: Z-3145-2024 · Reported September 25, 2024

    Enforcement

    Recall Number
    Z-3145-2024
    Event ID
    95167
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2024
    Initiation Date
    August 8, 2024
    Classification Date
    September 13, 2024
    Address
    Oskar-Schlemmer-Str. 11, Munich, N/A, Germany

    Description

    ViewPoint; system, imaging processing, radiological

    Reason

    The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.

    Code Info

    No UDI/DI, System ID numbers: QB7A TA99, N26D M0B7, Q1K1 FFQW

    Distribution

    US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

    Quantity

    3 units