BEUDAMED
    FDA Enforcement Class II Ongoing

    Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    Recall: Z-0299-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0299-2026
    Event ID
    97647
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2025
    Initiation Date
    September 12, 2025
    Classification Date
    October 23, 2025
    Address
    9, Andrey Sakharov, Haifa, N/A, Israel

    Description

    Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    Reason

    GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

    Code Info

    all serial numbers in distribution

    Distribution

    Worldwide

    Quantity

    292 units