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FocusRecalls & reported problems

PaloDEx Group Oy · Class 2

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 06430035872695), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Electrical Shock” (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

  • Unintended Electrical Shock1

Patient problems

  • Electric Shock1

Recent adverse event reports

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

  • MalfunctionDec 2, 2022Unintended Electrical Shock; Unintended Electrical Shock

    IT WAS REPORTED BY A DENTAL OFFICE THAT A STAFF MEMBER RECEIVED A SHOCK FROM THE UNIT WHILE PREPARING FOR CLINICAL USE. STAFF REPORTED SEEING A WHITE SPARK/ FLASH FROM THE BACK OF THE HORIZONTAL ARM WHERE IT MEETS THE WALL. NO INJURIES OR MEDICAL ATTENTION WAS REPORTED.

    Patient problems: Electric Shock

    MAUDE report 15907048 ↗

Other Unit, X-Ray, Extraoral With Timer devices

All Unit, X-Ray, Extraoral With Timer devices →

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