The Recall Desk

Manufacturer

SEDECAL SA

53 recalls in our database name SEDECAL SA as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 53

  • Severity pendingFDA (Devices)·Z-0246-2026·2025-10-29

    Model Number 40KWFXPLUS, Mobile X-ray system

    Pending LLM rewrite. Source: FDA_DEVICE Z-0246-2026.

    Product
    Model Number 40KWFXPLUS, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • Severity pendingFDA (Devices)·Z-0244-2026·2025-10-29

    Model Number 40KWFX, Mobile X-ray system

    Pending LLM rewrite. Source: FDA_DEVICE Z-0244-2026.

    Product
    Model Number 40KWFX, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • Severity pendingFDA (Devices)·Z-0281-2026·2025-10-29

    RADPRO MOBILE, Mobile X-ray system

    Pending LLM rewrite. Source: FDA_DEVICE Z-0281-2026.

    Product
    RADPRO MOBILE, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • Severity pendingFDA (Devices)·Z-0285-2026·2025-10-29

    SM_40HF_B_D_VIR3.004, Mobile X-ray system

    Pending LLM rewrite. Source: FDA_DEVICE Z-0285-2026.

    Product
    SM_40HF_B_D_VIR3.004, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • Severity pendingFDA (Devices)·Z-0260-2026·2025-10-29

    Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

    Pending LLM rewrite. Source: FDA_DEVICE Z-0260-2026.

    Product
    Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1754-2024·2024-05-08

    Battery Mobile X-ray Units Recalled for Anti-Fall System Interference

    SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING models worldwide due to potential interference with the anti-fall system.

    Product
    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2024·2024-02-21

    Portable X-ray system may move unexpectedly if improperly cleaned

    The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.

    Product
    MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2024·2024-01-31

    Medical X-Ray System Recall Due to Parts Falling Off

    Sedecal SA is recalling 845 Sedecal X Optima URS diagnostic x-ray systems after parts fell off the equipment, creating a safety risk to patients and users. The affected units were distributed in Alabama, Florida, and North Carolina.

    Product
    Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2045-2023·2023-07-05

    Mobile Digital X-Ray System Recall: Software Login Issue Affects Units

    SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.

    Product
    wDR 2.2 Mobile Digital Diagnostic X-Ray System
    Category
    Medical Device
    Distribution
    0 states