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SEDECAL Soltus 450 (REF 10451)Recalls & reported problems

Sedecal · Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436046002555), received between Apr 27, 2023 and Apr 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended System Motion” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 12, 2022Open, Classified

    Due to un-commanded movement of mobile x-ray unit.

    Z-0182-2023 · Root cause: Software design · FDA record ↗

Most reported problems

Device problems

  • Unintended System Motion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 27, 2023Unintended System Motion; Unintended System Motion

    EVENT DESCRIPTION: ERRATIC MOVEMENT AFTER GOING DOWN A RAMP OF 22 DEGREES. CUSTOMER DESCRIPTION: 4/10/2023 - SLIGHT MALFUNCTION THIS EVENING. IT SUDDENLY STARTED SWERVING, THEN BACKED UP ON ITS OWN REALLY FAST AND STOPPED MOVING ALL TOGETHER. I SHUT IT OFF AND TURNED IT BACK ON AND IT SEEMS TO BE WORKING FINE NOW. ADDITIONALLY, ANOTHER TECH REPORTED THE PORTABLE MOVING IN 360-DEGREE CIRCLES ON ITS OWN ON THURSDAY 4/13/23. ACTIONS ON GOING: MANUFACTURER AND DISTRIBUTOR WORKING IN THE INVESTIGATION FOR FINDING OUT THE ROOT CAUSE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16823113 ↗

Other Solid State X-Ray Imager (Flat Panel/Digital Imager) devices

All Solid State X-Ray Imager (Flat Panel/Digital Imager) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.