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X-Smart IQ XSIQEM1HSPRecalls & reported problems

Tulsa Dental Products LLC · X-Smart IQ Hand Piece · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 D716XSIQEM1HPS1), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • Insufficient Information1
  • 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.

  • MalfunctionJun 29, 2023Mechanical Problem; Mechanical Problem

    IN THIS EVENT IT IS REPORTED THAT A X-SMART IQ HANDPIECE STOPPED RUNNING DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 17225118 ↗

Other Controller, foot, handpiece and cord devices

All Controller, foot, handpiece and cord devices →

Sources and updates

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