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SEDECAL SHF-835Recalls & 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 08436046000438), received between Mar 21, 2023 and Mar 21, 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 21, 2023Fire; Fire

    PATIENT INVOLVED: NO. NO PATIENT WAS IN ROOM WHEN TECHNOLOGIST SAW SMOKE. INJURIES: NO. TECHNOLOGIST LEFT ROOM SO NO INJURY. ISSUE: ON (B)(6) 2023 AROUND 6:19PM THE TECHNOLOGIST WAS TAKING A BREAK AND WHEN HE CAN BACK INTO THE ROOM THE GENERATOR WAS SMOKING IT TRIGGERED THE FIRE ALARM SO THE FIRE DEPARTMENT CAME AND HAD TO PUT OUT THE FIRE BY A FIRE EXTINGUISHER. THE SITE CUT ALL WIRES FROM THE GENERATOR AND REMOVED IT FROM THE ROOM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16581992 ↗

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.