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SEDECAL Proteus XR/f ETRecalls & reported problems

Sedecal · The Proteus XR/f ET Radiographic Systems with (or without) Digital Detector are 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

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436046002302), received between Sep 11, 2020 and Sep 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

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.

  • MalfunctionSep 11, 2020Detachment of Device or Device Component

    THE COLLIMATOR FELL OFF TUBEHEAD. THE COLLIMATOR WAS REATTACHED. THERE WAS NO INJURY. THE COLLIMATOR DID DETACH AND FALL ON THE TABLE DUE TO A DEFECTIVE REASSEMBLY AFTER A SERVICE MAINTENANCE TASK AS THE TECHNOLOGIST WAS POSITIONING THE COLLIMATOR DURING A PATIENT CHEST EXAM, THE COLLIMATOR FELL FROM ITS MOUNT ONTO THE TABLE. IMPORTANT INFORMATION: THE COLLIMATOR WAS REMOVED THE DAY BEFORE TO REPLACE TUBE. THE TUBE WAS THEN PUT BACK AS IT WAS NOT THE CAUSE OF THE PROBLEM. THE SET SCREW WAS NOT ALL THE WAY IN. FIELD ENGINEER WENT TO SITE AND SCREWED THE SCREW BACK IN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10520409 ↗

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

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page