BEUDAMED
    FDA Enforcement Class II Ongoing

    Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

    Recall: Z-0242-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0242-2026
    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

    Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

    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 08436046002593, Serial Numbers: G-81478, G81924, G84618, G87981, G88006, G88007, G87866, G84607, G86618, G88041, G87427, G80991, G-81936, G86688, G-82904, G86360, G84340, G86372, G81471, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846.

    Distribution

    US: CA, IL, and NJ

    Quantity

    56 units