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.

51–53 of 53

  • HighFDA (Devices)·Z-1202-2023·2023-03-08

    Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements

    SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.

    Product
    Phoenix mKDR, digital mobile diagnostic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1203-2023·2023-03-08

    FDA Recalls Mobile X-Ray System for Erratic Movement Risk

    SEDECAL's Phoenix mKDR Xpress mobile x-ray system is recalled due to three reported incidents of erratic movements. Seven units distributed in the US, Argentina, and Panama are affected.

    Product
    Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0182-2023·2022-11-16

    Sedecal Soltus Battery Mobile X-Ray Systems Recalled for Unintended Movement

    Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.

    Product
    Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
    Category
    Medical Device
    Distribution
    36 states