BEUDAMED
    FDA Enforcement Class II Ongoing

    Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

    Recall: Z-0258-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0258-2026
    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

    Model Number SM-40HF-B-D-C; 40KW 50G, 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 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684.

    Distribution

    US: CA, IL, and NJ

    Quantity

    39 units