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SPEC 3 60013941Recalls & reported problems

Coltene/Whaledent Inc · SPEC 23 LED USA Plug Type A · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D661600139410), received between Mar 18, 2022 and Mar 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1
  • Overheating of Device1

Patient problems

  • Burn(s)1

Recent adverse event reports

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

  • InjuryMar 18, 2022Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

    FEMALE PATIENT WAS NUMBED, AND DR USED THE SPEC 3 LIGHT TO CURE THE FILLING MATERIAL. THE LIGHT WAS POINTED TOWARDS THE TOOTH, ON THE STANDARD MODE, AND THE LIGHT CAUSED A BURN TO FORM ON THE SIDE OF THE PATIENT'S TONGUE. THE PATIENT IS NOW IN PAIN FROM THE BURN, AND THE DR IS COMPLAINING THAT THE LIGHT IS GETTING TOO HOT AND OVERHEATING.

    Patient problems: Burn(s)

    MAUDE report 13807267 ↗

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Sources and updates

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