BEUDAMED
    FDA Enforcement Class II Ongoing

    GE HealthCare OEC 9900 Elite C-arm Systems.

    Recall: Z-2342-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2342-2025
    Event ID
    97454
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 3, 2025
    Initiation Date
    July 2, 2025
    Classification Date
    August 22, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE HealthCare OEC 9900 Elite C-arm Systems.

    Reason

    GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

    Code Info

    GTIN: 00840682114349

    Distribution

    US Nationwide distribution.