BEUDAMED
    FDA Enforcement Class II Ongoing

    SMV DSX New Line, System, Tomography, Computed, Emission

    Recall: Z-1044-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1044-2026
    Event ID
    98133
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 21, 2026
    Initiation Date
    December 10, 2025
    Classification Date
    January 9, 2026
    Address
    4, Hayozma St, Tirat Carmel, N/A, Israel

    Description

    SMV DSX New Line, System, Tomography, Computed, Emission

    Reason

    GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) 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. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

    Code Info

    UDI/DI Not applicable: All serial numbers in distribution

    Distribution

    US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

    Quantity

    7 units