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SEDECAL CS NOVA FARecalls & reported problems

Sedecal · Ceiling Mount X-ray tube stand · Class 1

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 08436046001930), received between Jun 25, 2018 and Jun 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Issue” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Issue1
  • Unintended System Motion1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionJun 25, 2018Unintended System Motion; Device Issue; Unintended System Motion; Device Issue

    THIS INCIDENT INVOLVES A MALFUNCTION IN A DIAGNOSTIC X-RAY SYSTEM, SPECIFICALLY THE OVERHEAD TUBE CRANE. THIS IS A CEILING MOUNTED DEVICE WHICH HOLDS THE X-RAY TUBE AND THE COLLIMATOR. THIS ASSEMBLY CAN BE MOVED BOTH HORIZONTALLY AND VERTICALLY. IN THIS CASE, THE ASSEMBLY FELL TO THE GROUND WITHOUT ANY COMMAND FROM THE OPERATOR TO DO THIS. HAD THERE BEEN A PERSON UNDERNEATH THE TUBE CRANE AT THE TIME, THAT PERSON COULD HAVE BEEN SEVERELY INJURED OR KILLED BECAUSE OF THE MASS INVOLVED.

    Patient problems: No Information

    MAUDE report 7633941 ↗

Other Tube Mount, X-Ray, Diagnostic devices

All Tube Mount, X-Ray, Diagnostic devices →

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