X-Smart IQ XSIQEM1BSKRecalls & reported problems
Tulsa Dental Products LLC · X-Smart IQ Basic · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D716XSIQEM1BSK1), received between Dec 11, 2024 and Jun 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Mechanical Problem; Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT A X-SMART IQ STOPS DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307378 ↗MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT A X-SMART IQ BASIC STARTER KIT STOPPED DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20903129 ↗
Other Controller, foot, handpiece and cord devices
- EM-19 Electric Motor 30185000W & H Dentalwerk Bürmoos GmbH · Controller, Foot, Handpiece And Cord1 report
- S-NW CAN-Bus 30264000W & H Dentalwerk Bürmoos GmbH · Controller, Foot, Handpiece And Cord1 report
- X-Smart IQ XSIQEM1HSPTulsa Dental Products LLC · Controller, foot, handpiece and cord1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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