BEUDAMED
    FDA Enforcement Class II Ongoing

    SM_40HF_B_D_VIR3, Mobile X-ray system

    Recall: Z-0284-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0284-2026
    Event ID
    97075
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SEDECAL SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 29, 2025
    Initiation Date
    June 10, 2025
    Classification Date
    October 23, 2025
    Address
    Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, N/A, Spain

    Description

    SM_40HF_B_D_VIR3, Mobile X-ray system

    Reason

    Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

    Code Info

    UDI/DI 08436046002166, Serial Numbers: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452.

    Distribution

    US: CA, IL, and NJ

    Quantity

    17 units