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SEDECAL SHFR500Recalls & reported problems

Sedecal · High frequency diagnostic x-ray generator · 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 08436046001374), received between Mar 27, 2023 and Mar 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (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

  • Fire1

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.

  • MalfunctionMar 27, 2023Fire; Fire

    TECHNOLOGIST STATED THEY WERE IMAGING A PATIENT THOUGHT THEY HEARD A POP AFTER THE LAST IMAGE. THEY LET THE PATIENT GO AND LEFT THE ROOM THEY CAME BACK IN AND SMELLED SMOKE THAN THEY SAW A FLAME COME OUT OF THE GENERATOR THEY KILLED THE POWER AND EVACUATED THE BUILDING AND CALLED THE FIRE DEPARTMENT THE FIRE DEPARTMENT CUT ALL THE CABLES TO THE GENERATOR AND MOVED THE GENERATOR OUT OF THE BUILDING. NO INJURY WAS REPORTED. THE GENERATOR CAUGHT FIRE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16618332 ↗

Other Generator, High-Voltage, X-Ray, Diagnostic devices

All Generator, High-Voltage, X-Ray, Diagnostic devices →

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