BEUDAMED
    FDA Recall Open, Classified

    SED URS LP, Mobile X-ray system

    Recall: Z-0282-2026 · Initiated June 10, 2025

    Recall

    Recall Number
    Z-0282-2026
    Event Number
    97075
    Firm
    SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain
    FEI Number
    3002495042
    Product Code
    IZL
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 10, 2025
    Posted
    October 23, 2025

    Description

    SED URS LP, 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.

    Action

    Sedecal emailed their distributors on 06/10/2025 to remind them 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. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.

    Distribution

    US: CA, IL, and NJ