The Recall Desk

Manufacturer

SEDECAL SA

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

What the numbers show

Total
53
Critical
0
Severe
0
Most recent
2025-10-29

Of the 53 recalls from SEDECAL SA we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

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

  • ModerateFDA (Devices)·Z-0271-2026·2025-10-29

    One hundred eighty one 40KW 70C X-ray systems recalled with cleaning reminder

    Sedecal is recalling 181 SM-40HF-B-D-C 40KW 70C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0278-2026·2025-10-29

    Six 40KW mobile X-ray units recalled with strict cleaning reminder

    Sedecal is recalling six SM-40HF-B-D-C 40KW.002 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0277-2026·2025-10-29

    One hundred forty two 40KW X-ray systems recalled with cleaning reminder

    Sedecal is recalling 142 SM-40HF-B-D-C 40KW mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0273-2026·2025-10-29

    Mobile X-ray systems recalled with cleaning reminder over water resistance limits

    Sedecal is recalling 10 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.

    Product
    Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0251-2026·2025-10-29

    Twelve mobile X-ray units recalled with reminder about water resistance limits

    Sedecal is recalling 12 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.

    Product
    Model Number 40KWFXPLUS-710CW, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0263-2026·2025-10-29

    Four 40KW 50C X-ray systems recalled with water resistance reminder

    Sedecal is recalling four SM-40HF-B-D-C 40KW 50C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0242-2026·2025-10-29

    Digital diagnostic X-ray systems recalled with reminder about improper cleaning

    Sedecal is recalling 56 SM-40HF-B-D-KM (AeroDR X30) mobile digital diagnostic X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0254-2026·2025-10-29

    Battery powered mobile X-ray unit recalled with water resistance reminder

    Sedecal is recalling one SM-20HF-Batt 20KW analog mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0257-2026·2025-10-29

    Canon ready 40KW systems recalled with reminder about improper cleaning

    Sedecal is recalling six SM-40HF-B-D-C 40KW Canon Ready mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0258-2026·2025-10-29

    Thirty nine 40KW 50G X-ray systems recalled with cleaning reminder

    Sedecal is recalling 39 SM-40HF-B-D-C 40KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0262-2026·2025-10-29

    Easy Moving Plus X-ray systems recalled with water resistance reminder

    Sedecal is recalling eight Easy Moving Plus SM-50HF-B-D-C 50KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0267-2026·2025-10-29

    Forty kilowatt 55G X-ray systems recalled with water resistance reminder

    Sedecal is recalling five SM-40HF-B-D-C 40KW 55G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0255-2026·2025-10-29

    Thirty two kilowatt X-ray systems recalled with strict cleaning reminder

    Sedecal is recalling eight SM-32HF-B-D-C 32KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-32HF-B-D-C; 32KW 50G, 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
    2 states